Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
2,500
Countries
2
Sites
14
Venous thromboembolism
To determine the primary outcome event rate (i.e. symptomatic recurrent major VTE [proximal DVT or segmental or larger PE]) in patients taking generic rosuvastatin compared to placebo
Key facts
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest, Ostfold Hospital Trust, Ottawa Hospital Research Institute
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 29 May 2024 → ongoing
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- The Canadian Institutes of Health Research (CIHR)
External identifiers
- EU CT number
- 2023-504486-23-00
- EudraCT number
- 2021-001559-15
- ClinicalTrials.gov
- NCT04319627
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To determine the primary outcome event rate (i.e. symptomatic recurrent major VTE [proximal DVT or segmental or larger PE]) in patients taking generic rosuvastatin compared to placebo
Secondary objectives 5
- To determine the major bleeding event rate in patients taking generic rosuvastatin compared to placebo.
- To explore if rosuvastatin reduces the incidence of PTS, as measured by the Villalta scale at end of study.
- To determine if rosuvastatin reduces the incidence of arterial vascular events
- To determine if rosuvastatin reduces the incidence of recurrent non-major VTE
- To determine the safety of rosuvastatin
Conditions and MedDRA coding
Venous thromboembolism
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10037379 | Pulmonary embolism and thrombosis | 10047065 |
| 21.1 | LLT | 10066529 | Deep vein thrombosis recurrent | 10047065 |
| 21.1 | LLT | 10043630 | Thrombosis of leg deep venous | 10047065 |
| 20.1 | PT | 10066881 | Deep vein thrombosis postoperative | 100000004863 |
| 21.1 | LLT | 10037436 | Pulmonary thromboembolism | 10038738 |
| 20.0 | LLT | 10043642 | Thrombosis venous deep | 10047065 |
| 21.1 | LLT | 10024105 | Left deep vein thrombosis | 10047065 |
| 21.0 | PT | 10037377 | Pulmonary embolism | 100000004855 |
| 21.1 | LLT | 10000853 | Acute massive pulmonary embolism | 10038738 |
| 20.0 | LLT | 10014521 | Embolism pulmonary | 10038738 |
| 21.1 | PT | 10051055 | Deep vein thrombosis | 100000004866 |
| 20.0 | PT | 10063909 | Post procedural pulmonary embolism | 100000004863 |
| 21.0 | PT | 10047249 | Venous thrombosis | 100000004866 |
| 21.1 | LLT | 10065052 | Deep vein thrombosis leg | 10047065 |
| 21.1 | LLT | 10049918 | Deep venous thrombosis proximal | 10047065 |
| 21.1 | LLT | 10047251 | Venous thrombosis deep (limbs) | 10047065 |
| 20.0 | LLT | 10073531 | Iliofemoral deep vein thrombosis | 10047065 |
| 21.0 | LLT | 10080372 | Leg venous thrombosis | 10047065 |
| 20.0 | PT | 10037459 | Pulmonary venous thrombosis | 100000004855 |
| 21.1 | LLT | 10066738 | Recurrent pulmonary embolism | 10038738 |
| 21.1 | LLT | 10049916 | Deep venous thrombosis femoral | 10047065 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in the last 30 days.
Exclusion criteria 10
- Unable or unwilling to provide written informed consent
- < 18 years of age
- Women of childbearing potential unwilling to use appropriate contraception
- Currently prescribed a statin
- A known medical history or current diagnosis of any of the following for which statins are indicated in secondary prevention: a) Diabetes; b) Abdominal aortic aneurysm; c) Peripheral arterial disease; d) Stroke; e) Transient ischemic attack (TIA); f) Myocardial infarction (MI); g) Acute coronary syndromes; h) Stable/unstable angina; i) Coronary or other arterial revascularization
- Known diagnosis of hypercholesterolemia or dyslipidemia
- Contraindication to rosuvastatin; a) Known hypersensitivity or intolerance to statins; b) History of muscle disorders or statin-related muscle pain; c) Known liver disease (active liver disease, e.g. Hepatitis A, B, C, non-alcoholic fatty liver); d) Chronic kidney disease (creatinine clearance < 30ml/min); e) Currently pregnant or breast feeding; f) Taking cyclosporine; g) Taking atazanavir/ritonavir; h) Taking darolutamide; i) Taking regorafenib
- Unstable medical or psychological condition that would interfere with trial participation
- Life expectancy less than 3 months
- Patient without social security affiliation or not beneficiary of such social security (Criteria for France)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Symptomatic recurrent major VTE (proximal DVT or segmental or larger PE) occurring between randomization and the end of follow-up (i.e. completion of the trial) in patients taking generic rosuvastatin.
Secondary endpoints 4
- Post-thrombotic syndrome as measured by the Villalta score
- Non-major VTE; a) Distal DVT (distal to the trifurcation of the popliteal vein); b) Isolated sub-segmental PE; c) Upper Extremity DVT; d) Unusual site DVT; e) Superficial vein thrombosis
- Arterial vascular events: o Fatal myocardial infarction o Non-fatal myocardial infarction o Hospitalization for unstable angina o Coronary artery revascularization o Sudden cardiac death o Ischemic stroke
- All-cause mortality (no adjudication required)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB20721 · Substance
- Active substance
- Rosuvastatin Calcium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo Rosuvastatin Calcium 20 mg tablets
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Et Universitaire De Brest
- Sponsor organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Address
- 2 Avenue Marechal Foch
- City
- Brest
- Postcode
- 29200
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Francis COUTURAUD
Public contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Francis COUTURAUD
Ostfold Hospital Trust
- Sponsor organisation
- Ostfold Hospital Trust
- Address
- P. O. Box 16
- City
- Fredrikstad
- Postcode
- 1603
- Country
- Norway
Scientific contact point
- Organisation
- Ostfold Hospital Trust
- Contact name
- Waleed Ghanima
Public contact point
- Organisation
- Ostfold Hospital Trust
- Contact name
- Waleed Ghanima
Ottawa Hospital Research Institute
- Sponsor organisation
- Ottawa Hospital Research Institute
- Address
- 501 Smyth Road
- City
- Ottawa
- Postcode
- K1H 8L6
- Country
- Canada
Scientific contact point
- Organisation
- Ottawa Hospital Research Institute
- Contact name
- Aurelien Delluc
Public contact point
- Organisation
- Ottawa Hospital Research Institute
- Contact name
- Aurelien Delluc
Sponsor responsibilities
- Article 77 compliance
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact point sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
Locations
2 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 600 | 12 |
| Norway | Ongoing, recruiting | 150 | 2 |
| Rest of world
Australia, Canada
|
— | 1,750 | — |
Investigational sites
CHU Gabriel-Montpied
63, 58 Rue Montalembert, 63000, Clermont Ferrand
Hôpital NOVO - Site de Pontoise
95, 6 Avenue de l'Île de France, 95303, Cergy Pontoise
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
83, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Centre Hospitalier Regional Et Universitaire De Brest
29, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
17, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Centre Hospitalier Universitaire De Saint Etienne
42, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Assistance Publique Hopitaux De Paris
92, 178 Rue Des Renouillers, 92701, Colombes Cedex
Centre Hospitalier Regional D'Angers
49, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Dijon
21, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Des Pays De Morlaix
Pneumology, 15 Rue De Kersaint Gilly, Bp 97237, Morlaix
Direction Centrale Du Service De Sante Des Armees
Pneumology, Rue Colonel Fonferrier, 29200, Brest
Centre Hospitalier Universitaire Rouen
Internal Medicine, 1 Rue De Germont, Bp 96031, Rouen Cedex
Ostfold Hospital Trust
Clinic of Internal Medicine Kalnes, P. O. Box 16, 1603, Fredrikstad
Akershus University Hospital
Department of Haematology, Sykehusveien 25, 1474, Loerenskog
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 | 2025-05-09 | 2025-05-09 | |||
| Norway | 2024-05-29 | 2024-05-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2024-08-05
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with CTR Q&A / point 1.23, the sponsor is asked to submit a substantial modification application in order to update the CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol - Extract (for publication) | D4_Patient facing document France Villalta scale | 1.0 |
| Protocol - Extract (for publication) | D4_Patient facing documents France EQ-5D-5L questionnaire | 1.2 |
| Protocol (for publication) | D1_Protocol 2023-504486-23-00 | 7.0 |
| Protocol (for publication) | D1_Protocol 2023-504486-23-00_ Tracked Changes | 7.0 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recrutement arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recrutement arrangements_FR | 1 |
| Subject information and informed consent form (for publication) | D4_Patient facing documents Norway EQ-5D-5L questionnaire | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult_NO_Tracked change | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Tracked changes | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Tracked Changes | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF infant follow-up | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnancy_Tracked changes | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter to GP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient wallet card_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient wallet card_NO | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC rosuvastatin calcium 20mg | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-504486-23-00 | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-504486-23-00 final | 4.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-504486-23-00_tracked change | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO 2023-504486-23-00 | 4.3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO 2023-504486-23-00 tracked Changes | 4.3 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-06 | Norway | Acceptable 2023-07-24
|
2023-07-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-08 | Norway | Acceptable 2023-11-22
|
2023-11-22 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-02-06 | Acceptable 2023-11-22
|
2024-03-29 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-12 | Norway | Acceptable 2024-05-23
|
2024-05-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-14 | Norway | Acceptable 2024-11-15
|
2024-11-19 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-11 | Norway | Acceptable 2025-09-15
|
2025-09-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-06 | Acceptable | 2026-03-18 |