Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,400
Countries
1
Sites
32
acute venous thromboembolism event
To demonstrate the superiority of full-dose anticoagulant therapy alone on the risk of clinically relevant bleeding, when compared to the combination of antiplatelet and full-dose anticoagulant therapy, in patients with acute VTE receiving antiplatelet for secondary arterial prevention (at the time of VTE diagnosis).
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Saint Etienne, Centre Hospitalier Universitaire De Saint Etienne
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 12 Aug 2023 → ongoing
- Decision date (initial)
- 2023-04-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- French Ministry of Health
External identifiers
- EU CT number
- 2022-500974-33-00
- ClinicalTrials.gov
- NCT05627375
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To demonstrate the superiority of full-dose anticoagulant therapy alone on the risk of clinically relevant bleeding, when compared to the combination of antiplatelet and full-dose anticoagulant therapy, in patients with acute VTE receiving antiplatelet for secondary arterial prevention (at the time of VTE diagnosis).
Secondary objectives 5
- According to hierarchical analysis, the secondary key objective will be to demonstrate the superiority of the full-dose anticoagulant therapy alone, compared to the combination of antiplatelet and full-dose anticoagulant therapy, on the net clinical benefit.
- Exploratory secondary objective will assess the safety (in terms of clinically relevant bleeding) of the full-dose anticoagulant therapy alone compared to combination of antiplatelet and full-dose anticoagulant therapy according to VTE circumstances (VTE provoked by a major transient factor, unprovoked VTE, cancer-associated VTE)
- Exploratory secondary objective will assess the safety (in terms of major bleeding) of the full-dose anticoagulant therapy alone compared to combination of antiplatelet and full-dose anticoagulant therapy.
- Exploratory secondary objective will assess the efficacy (in terms of vascular events) of full-dose anticoagulant therapy alone compared to combination of antiplatelet and full-dose anticoagulant therapy.
- Exploratory secondary objective will assess the efficacy (in terms of VTE sequels) of full-dose anticoagulant therapy alone compared to combination of antiplatelet and full-dose anticoagulant therapy
Conditions and MedDRA coding
acute venous thromboembolism event
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10049918 | Deep venous thrombosis proximal | 10047065 |
| 21.1 | LLT | 10051615 | Atherosclerotic cardiovascular disease | 10047065 |
| 21.1 | LLT | 10067625 | Secondary prevention | 10042613 |
| 20.0 | LLT | 10014521 | Embolism pulmonary | 10038738 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | study treatment: full dose anticoagulant treatment Duration of study treatment = duration of full dose anticoagulant treatment at the investigator's discretion
Patient with a long term anticoagulant treatment = duration of study treatment = 12 months
|
Randomised Controlled | None | Experimental group: full-dose anticoagulant tretament alone (AC) (=antiplatelet stopped): All anticoagulant treatments with the marketing authorization in the treatment of VTE. Choice of treatment is at the investigator's discretion: 1) DOAC (Direct Oral Anticoagulant) : • Rivaroxaban (Xarelto®) at a fixed dosage of 15 mg x 2 / day for 21 days then 20 mg x 1 / day orally. • Apixaban (Eliquis®) at a fixed dosage of 10 mg x 2 / day for 7 days then 5 mg x 2 / day orally. Duration of study treatment = duration of full dose DOAC at the investigator's discretion Patient with a long term DOAC term = duration of study treatment = 12 months 2) VKA: • warfarin (Coumadine®), • or acenocoumarol (Sintrom®) VKA prescribed as a relay to parenteral treatment (UFH, LMWH or fondaparinux) in order to maintain an INR between 2 and 3. - LMWH (Low Molecular Weight Heparin) • enoxaparin (Lovenox®) at a fixed dosage of 100 IU / kg x 2 / day subcutaneously for at least 5 days during the VKA relay time. • or tinzaparin (Innohep®) at a fixed dosage of 175 IU/kg x 1 / day subcutaneously for at least 5 days during the VKA relay period. - Fondaparinux (Arixtra®): 7.5 mg x 1 / day subcutaneously (5 mg x 1 / day if body weight is less than 50 kg or 10 mg x 1 / day if body weight is more than 100 kg) for at least 3 days during the VKA relay. - UFH (UnFractionned Heparin) (Calciparine®, Choay® heparin, panpharma® sodium heparin): optional bolus of 50 IU / kg then continuous intravenous or subcutaneous infusion (in 2 or 3 injections / day) at a dose of 18 IU / kg / hour then adapted to obtain an anti-factor Xa activity of between 0.3 IU and 0.6 IU / ml for at least 3 days. The anti-factor Xa activity required to monitor treatment with UFH will be measured according to the methods used in each of the centres. 3) For patients with cancer, • tinzaparin (Innohep®) at a fixed dosage of 175 IU/kg x 1 / day subcutaneously. • Dalteparin (Fragmine®) at a fixed dosage of 200 IU/kg x 1 / day subcutaneously for 1 month, then 150 IU/kg x 1 / day. Control group: full-dose anticoagulant treatment + antiplatelet treatment (AC+ AP): Choice of antiplatelet treatment is at the investigator's discretion: - aspirin (at a daily dose ≤100 mg) - or clopidogrel (at 75 mg per day) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients with acute objectively confirmed symptomatic proximal deep-vein thrombosis (DVT) or pulmonary embolism (PE) (with or without deep-vein thrombosis). Proximal deep-vein thrombosis is defined as thrombosis involving at least the popliteal vein or a more proximal vein of the lower limb.
- Indication of full-dose anticoagulant therapy for at least 3 months.
- Prescription of antiplatelet therapy for secondary prevention of atherosclerotic cardiovascular diseases, at the time of VTE diagnosis
Exclusion criteria 9
- Active bleeding or a high risk of bleeding contraindicating anticoagulant treatment; a systolic blood pressure of more than 180 mm Hg or a diastolic blood pressure of more than 110 mm Hg
- Anticoagulation for more than 7 days prior to randomization
- Active pregnancy or expected pregnancy or no effective contraception
- Isolated distal deep vein thrombosis
- Antiplatelet therapy prescribed for primary prevention of cardiovascular disease
- Indication to maintain a dual-antiplatelet therapy
- Triple positive antiphospholipide syndrome, with arterial thrombosis
- Major cardiovascular and cerebrovascular event in the past 12 months for acute coronary syndrom, and in the past 6 months for cerebrovascular diseases and peripheral arterial diseases
- Isolated sub-segmental pulmonary embolism
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinically relevant bleeding (=composite of major bleeding events and clinically relevant non-major bleeding events (according to the ISTH)) at the end of the full-dose treatment period (or up to 12 months).
Secondary endpoints 5
- o Net clinical benefit is defined by the composite of clinically relevant bleeding, recurrent venous thromboembolism and major adverse ischemic cardiovascular and cerebrovascular events, at the end of the full-dose treatment period, or up to 12 months
- o Clinically relevant bleeding
- o Major bleeding
- o Vascular events are the composite of recurrent venous thromboembolism, major adverse cardiovascular and cerebrovascular events
- o VTE sequels are the composite of post-thrombotic syndrome and/or post-PE syndrome
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
CALCIPARINE SOUS CUTANEE 20 000 UI/0,8 ml, solution injectable
PRD8643816 · Product
- Active substance
- Heparin Calcium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 IU/Kg iu/kilogram
- Max total dose
- 500 IU/kg international unit(s)/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB01 — HEPARIN
- Marketing authorisation
- 34009 556 707 1 1
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
HEPARINE CHOAY 5 000 UI/1 ml, solution injectable
PRD8643800 · Product
- Active substance
- Heparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 480 IU international unit(s)
- Max total dose
- 480 IU/kg international unit(s)/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB01 — HEPARIN
- Marketing authorisation
- 34009 552 438 6 1
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eliquis 5 mg film-coated tablets
PRD2351290 · Product
- Active substance
- Apixaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — -
- Marketing authorisation
- EU/1/11/691/009
- MA holder
- BRISTOL-MYERS SQUIBB/PFIZER EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SINTROM 4 mg, comprimé quadrisécable
PRD3993281 · Product
- Active substance
- Acenocoumarol
- Substance synonyms
- NICOUMALONE, ACENOCUMARIN
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2 U unit(s)
- Max total dose
- 3 U unit(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AA07 — ACENOCOUMAROL
- Marketing authorisation
- 34009 335 643 0 8
- MA holder
- MERUS LABS LUXCO II S.À R.L.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
COUMADINE 5 mg, comprimé sécable
PRD8913053 · Product
- Active substance
- Warfarin Sodium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 3 U unit(s)
- Max total dose
- 3 U unit(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AA03 — WARFARIN
- Marketing authorisation
- 34009 356 930 9 9
- MA holder
- TEOFARMA S.R.L.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
LOVENOX 10 000 UI (100 mg)/1 ml, solution injectable en seringue préremplie
PRD432352 · Product
- Active substance
- Enoxaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 200 IU/kg international unit(s)/kilogram
- Max total dose
- 200 IU/Kg iu/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- 34009 336 062 1 3
- MA holder
- SANOFI-AVENTIS FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FRAGMINE 7 500 U.l. anti Xa/0,75 ml, solution injectable en seringue pré-remplie
PRD422445 · Product
- Active substance
- Dalteparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 200 IU/kg international unit(s)/kilogram
- Max total dose
- 200 IU/kg international unit(s)/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB04 — DALTEPARIN
- Marketing authorisation
- 34009 337 307 8 9
- MA holder
- PFIZER HOLDING FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xarelto 10 mg film-coated tablets
PRD3003287 · Product
- Active substance
- Rivaroxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — -
- Marketing authorisation
- EU/1/08/472/001
- MA holder
- BAYER AG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
INNOHEP 4 500 UI anti-Xa/0,45 ml, solution injectable en seringue préremplie
PRD393927 · Product
- Active substance
- Tinzaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 175 IU/Kg iu/kilogram
- Max total dose
- 175 IU/Kg iu/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB10 — TINZAPARIN
- Marketing authorisation
- 34009 342 169 9 2
- MA holder
- LABORATOIRES LEO
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
PRD8805612 · Product
- Active substance
- Fondaparinux Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 7.5 mg milligram(s)
- Max total dose
- 7.5 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AX05 — FONDAPARINUX
- Marketing authorisation
- EU/1/02/206/012
- MA holder
- MYLAN IRE HEALTHCARE LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 13
INNOHEP 10 000 UI anti-Xa/0,5 ml, solution injectable en seringue préremplie
PRD394523 · Product
- Active substance
- Tinzaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 175 IU/kg international unit(s)/kilogram
- Max total dose
- 175 IU/kg international unit(s)/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB10 — TINZAPARIN
- Marketing authorisation
- 34009 339 723 9 4
- MA holder
- LABORATOIRES LEO
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
COUMADINE 2 mg, comprimé sécable
PRD8913037 · Product
- Active substance
- Warfarin Sodium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 3 U unit(s)
- Max total dose
- 3 U unit(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AA03 — WARFARIN
- Marketing authorisation
- 34009 302 645 4 6
- MA holder
- TEOFARMA S.R.L.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CALCIPARINE SOUS CUTANEE 12 500 UI/0,5 ml, solution injectable
PRD8643817 · Product
- Active substance
- Heparin Calcium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 IU/kg international unit(s)/kilogram
- Max total dose
- 500 IU/kg international unit(s)/kilogram
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AB01 — HEPARIN
- Marketing authorisation
- 34009 313 310 9 4
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
HEPARINE CHOAY 25 000 UI/5 ml, solution injectable
PRD8643797 · Product
- Active substance
- Heparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 480 IU/kg international unit(s)/kilogram
- Max total dose
- 480 IU/kg international unit(s)/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB01 — HEPARIN
- Marketing authorisation
- 34009 304 845 0 0
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xarelto 15 mg film-coated tablets
PRD2976438 · Product
- Active substance
- Rivaroxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AF01 — -
- Marketing authorisation
- EU/1/08/472/036
- MA holder
- BAYER AG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eliquis 5 mg film-coated tablets
PRD1722225 · Product
- Active substance
- Apixaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AF02 — -
- Marketing authorisation
- EU/1/11/691/014
- MA holder
- BRISTOL-MYERS SQUIBB/PFIZER EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RESITUNE 100 mg, comprimé gastro-résistant
PRD2866063 · Product
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 34009 300 140 0 4
- MA holder
- PFIZER HOLDING FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
LOVENOX 10 000 UI (100 mg)/1 ml, solution injectable en seringue préremplie
PRD4389774 · Product
- Active substance
- Enoxaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 200 IU/kg international unit(s)/kilogram
- Max total dose
- 200 IU/kg international unit(s)/kilogram
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- 34009 336 061 5 2
- MA holder
- SANOFI-AVENTIS FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
PRD8805614 · Product
- Active substance
- Fondaparinux Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 7.5 mg milligram(s)
- Max total dose
- 7.5 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AX05 — FONDAPARINUX
- Marketing authorisation
- EU/1/02/206/014
- MA holder
- MYLAN IRE HEALTHCARE LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KARDEGIC 75 mg, poudre pour solution buvable en sachet-dose
PRD432444 · Product
- Active substance
- D,L-Lysine Acetylsalicylate
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06, N02BA01 — ACETYLSALICYLIC ACID, ACETYLSALICYLIC ACID
- Marketing authorisation
- 34009 347 441 9 8
- MA holder
- SANOFI-AVENTIS FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Plavix 75 mg film-coated tablets
PRD2912264 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- EU/1/98/069/001
- MA holder
- SANOFI-AVENTIS GROUPE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SINTROM 4 mg, comprimé quadrisécable
PRD3990489 · Product
- Active substance
- Acenocoumarol
- Substance synonyms
- NICOUMALONE, ACENOCUMARIN
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 3 U unit(s)
- Max total dose
- 3 U unit(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AA07 — ACENOCOUMAROL
- Marketing authorisation
- 34009 335 580 9 3
- MA holder
- MERUS LABS LUXCO II S.À R.L.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FRAGMINE 10 000 U.l. anti Xa/1 ml, solution injectable en seringue pré-remplie
PRD422348 · Product
- Active substance
- Dalteparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 200 IU/kg international unit(s)/kilogram
- Max total dose
- 200 kg kilogram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AB04 — DALTEPARIN
- Marketing authorisation
- 34009 337 308 4 0
- MA holder
- PFIZER HOLDING FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Saint Etienne
- Sponsor organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Address
- 25 Boulevard Pasteur
- City
- Saint-Etienne
- Postcode
- 42100
- Country
- France
Scientific contact point
- Organisation
- CHU De Saint Etienne
- Contact name
- project manager
Public contact point
- Organisation
- CHU De Saint Etienne
- Contact name
- project manager
Centre Hospitalier Universitaire De Saint Etienne
- Sponsor organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Address
- 25 Boulevard Pasteur
- City
- Saint-Etienne
- Postcode
- 42100
- Country
- France
Locations
1 EU/EEA country · 32 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 1,400 | 32 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Cardiologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Centre Hospitalier Universitaire De Poitiers
Cardiologie, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Nice
Cardiologie, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Lille
Unité de soins intensifs cardiologiques, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Yves Le Foll
Médecine interne, 10 Rue Marcel Proust, 22000, Saint-Brieuc
Centre Hospitalier Universitaire De Nantes
Médecine Interne et Vasculaire, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Besancon University Hospital Center
Cardiologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Hôpital le corbusier
médecine vasculaire, 2 rue Robert Ploton, 42704, Firminy
Centre Hospitalier Universitaire Grenoble Alpes
Médecine interne, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Centre Hospitalier Regional D'Angers
Médecine Vasculaire, 4 Rue Larrey, 49100, Angers
Hopital D'Instruction Des Armees Percy
92, 101 Avenue Henri Barbusse, 92140, Clamart
Assistance Publique Hopitaux De Marseille
Vasculaire, 264 Rue Saint Pierre, 13005, Marseille
CHU De Saint Etienne
médecine vasculaire et thérapeutique, 25 Boulevard Pasteur, 42055, Saint-Etienne Cedex 2
Hospices Civils De Lyon
Médecine Vasculaire, 5 Place D Arsonval, 69437, Lyon Cedex 03
Centre Hospitalier Universitaire De Montpellier
Médecine interne et maladies vasculaires, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier Regional Et Universitaire De Brest
Médecine interne et pneumologie, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Centre Hospitalier Universitaire De Dijon
Angiologie, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier De Cholet
49, 1 Rue De Marengo, 49300, Cholet
Centre Hospitalier Universitaire Amiens Picardie
Médecine vasculaire, 1 Place Victor Pauchet, 80080, Amiens
Assistance Publique Hopitaux De Paris
Médecine interne, 178 Rue Des Renouillers, 92700, Colombes
Centre Hospitalier Universitaire De Limoges
Médecine Vasculaire, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer
Médecine Vasculaire, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Les Hopitaux Universitaires De Strasbourg
Maladies Vasculaires et Hypertension, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
CHRU De Nancy
Médecine Vasculaire, Vandoeuvre-Les-Nancy Cedex, 11 Rue Du Morvan, Vandoeuvre Les Nancy Cedex
Centre Hospitalier Universitaire De Toulouse
Médecine interne, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Regional Universitaire De Tours
Unité se Soins Cardiologiques Intensifs, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Bicetre Hospital
Pneumologie, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Assistance Publique Hopitaux De Paris
Pneumologie et soins intensifs, 20 Rue Leblanc, 75908, Paris Cedex 15
Centre Hospitalier Du Puy
Cardiologie, 12 Boulevard Docteur Chantemesse, 43000, Le Puy-En-Velay
CHU Gabriel-Montpied
Urgences, 58 Rue Montalembert, 63000, Clermont Ferrand
Centre Hospitalier Lyon Sud
Médecine Interne et Vasculaire, 165 Chemin Du Grand Revoyet, 69495, Pierre Benite Cedex
CHU De Rouen
Médecine Interne, 1 Rue De Germont, 76031, Rouen Cedex
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-08-12 | 2023-08-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 35 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2022-500974-33-00_PROTOCOL_BAT-VTE_TC | 4.1 |
| Protocol (for publication) | 2022-500974-33-00_PROTOCOL_BATVTE | 4.1 |
| Recruitment arrangements (for publication) | 2022-500974-33-00_RECRUITEMENT_BAT-VTE | 1 |
| Subject information and informed consent form (for publication) | 2022-500974-33-00_NIFC_BAT-VTE | 3 |
| Subject information and informed consent form (for publication) | 2022-500974-33-00_NIFC_BAT-VTE_TC | 3 |
| Subject information and informed consent form (for publication) | 2022-500974-33-00_NIFC_Personne-de-Confiance_BAT-VTE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_SM2_2022-500974-33-00 | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_SM2_2022-500974-33-00_TC | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF support person_SM2_2022-500974-33-00 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF support person_SM2_2022-500974-33-00_TC | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | arixtra | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | arixtra | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Calciparine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Calciparine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Coumadine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Coumadine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Eliquis-Apixaban | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Eliquis-Apixaban | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Fragmine - dalteparin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Fragmine - dalteparin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | heparine choay | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | heparine choay | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Innohep - tinzaparin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Innohep - tinzaparin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Kardegic 75mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | lovenox | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | lovenox | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Plavix clopidogrel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RESITUNE 100 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | sintrom | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | sintrom | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Xarelto-rivaroxaban | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Xarelto-rivaroxaban | 1 |
| Synopsis of the protocol (for publication) | 2022-500974-33-00_FRENCH_SYNOPSIS_BAT-VTE | 4 |
| Synopsis of the protocol (for publication) | 2022-500974-33-00_FRENCH_SYNOPSIS_SM1_BAT-VTE_TC | 4 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-06 | France | Acceptable 2023-03-20
|
2023-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-23 | France | Acceptable 2023-12-29
|
2024-01-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-01 | France | Acceptable 2024-11-06
|
2024-11-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-11 | France | Acceptable 2025-03-14
|
2025-03-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-21 | France | Acceptable | 2025-04-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-01-30 | France | Acceptable | 2026-02-18 |