Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
240
Countries
1
Sites
13
Acute Ischemic Stroke
To assess the efficacy and safety of the use of tirofiban versus aspirin in patients with ischemic stroke secondary to tandem injury, by determining the rate of reocclusion as well as determining the rate of symptomatic bleeding defined as any hemorrhagic transformation associated with a worsening of 4 or more points o…
Key facts
- Sponsor
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 1 May 2022 → 20 Mar 2026
- Decision date (initial)
- 2024-04-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Institute of Health Carlos III (ISCIII)
External identifiers
- EU CT number
- 2023-508454-26-00
- EudraCT number
- 2021-003874-30
- ClinicalTrials.gov
- NCT05225961
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy, Prophylaxis
To assess the efficacy and safety of the use of tirofiban versus aspirin in
patients with ischemic stroke secondary to tandem injury, by
determining the rate of reocclusion as well as determining the rate of
symptomatic bleeding defined as any hemorrhagic transformation
associated with a worsening of 4 or more points on the National
Institutes of Health Stroke Scale
Secondary objectives 5
- Determine the rescue therapy rate in the presence of intra-stent aggregation phenomena during the procedure
- Detection of good functional prognosis rates at 90 days in the different subgroups (defined as a score on the modified Rankin scale (mRS) between 0-2).
- Improve the pathophysiological knowledge of the complications associated with the endovascular treatment of tandem lesions (reocclusion) through the identification of related plasma biomarkers.
- Assessment of any of the biomarkers identified as a therapeutic target for reocclusion.
- Reocclusion or significant restenosis at 30 days.
Conditions and MedDRA coding
Acute Ischemic Stroke
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10055221 | Ischemic stroke | 10029205 |
| 20.0 | SOC | 10047065 | Vascular disorders | 12 |
| 20.0 | HLGT | 10003216 | Arteriosclerosis stenosis vascular insufficiency and necrosis | 10047065 |
| 22.1 | PT | 10061256 | Ischaemic stroke | 100000004852 |
| 20.0 | HLT | 10008192 | Cerebrovascular and spinal necrosis and vascular insufficiency | 10047065 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients with acute ischemic stroke of the anterior territory secondary to a tandem lesion, with an indication for thrombectomy treatment according to the current recommendations of the Clinical Practice Guidelines, and the need for cervical stent placement.
- The intracranial occlusion locations that may be included are: carotid "T", M1 and M2 segments of the middle cerebral artery, segment A1 of the anterior cerebral artery; and in the case that the posterior cerebral artery has fetal origin and is the site of intracranial occlusion.
- ASPECTS (Alberta Stroke Program Early computerized Tomography Score) ≥6.
- Greater than or equal to 18 years of age.
- Signed informed consent.
Exclusion criteria 16
- Patients under 18 years of age.
- Patients with ASPECTS <6.
- Bilateral strokes or those produced by simultaneous occlusion of an artery in the anterior and posterior territory.
- Patients whose carotid stenosis is due to a re-stenosis or reocclusion of a pre-existing cervical stent.
- Candidate patients for carotid puncture.
- Previous treatment with double antiplatelet therapy for another cause prior to inclusion.
- Severe comorbidity and / or reduced life expectancy.
- Modified Rankin scale (mRS)> 2.
- Severe allergy to contrast medium.
- Pregnant.
- Patients with intracranial occlusive arteriosclerotic disease or extra or intracranial dissection.
- Documented allergy to acetylsalicylic acid or Tirofiban.
- Personal history of platelet penia (Platelets <100,000)
- Concomitant anticoagulant treatment (with presence of INR (International Normalized Ratio) > 1.7 in case of anti-vitamin K treatment or taking direct oral anticoagulant <48 hours ago)
- Medical history of the patient that carries a high risk of bleeding according to the investigator's criteria.
- Peptic ulcer active in the last 3 months.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Carotid Reocclusion
- Platelet aggregation phenomena
- Symptomatic intracranial hemorrhage (sICH)
Secondary endpoints 1
- Good functional prognosis, Defined as a score on the modified rankin scale (mRS) between 0-2 at 90 days.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
AGRASTAT 50 microgrammes/ml, solution pour perfusion
PRD1680871 · Product
- Active substance
- Tirofiban Hydrochloride Monohydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 500 µg microgram(s)
- Max total dose
- 5283.4 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC17 — TIROFIBAN
- Marketing authorisation
- 34009 563 232 5 8
- MA holder
- CORREVIO
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD7930737 · Product
- Active substance
- D,L-Lysine Acetylsalicylate
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02BA — SALICYLIC ACID AND DERIVATIVES
- Marketing authorisation
- 51209
- MA holder
- ARISTO PHARMA IBERIA, S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Clopidogrel TecniGen 75 mg comprimidos recubiertos con película EFG
PRD10467054 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 2475 mg milligram(s)
- Max treatment duration
- 30 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- 71.773
- MA holder
- TECNIMEDE ESPAÑA IND. FCA., S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD430590 · Product
- Active substance
- Acetylsalicylic Acid
- Substance synonyms
- ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 9200 mg milligram(s)
- Max treatment duration
- 90 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 42.991
- MA holder
- OPELLA HEALTHCARE SPAIN, S.L
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Sponsor organisation
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Address
- Avenida De Manuel Siurot S/n
- City
- Sevilla
- Postcode
- 41013
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Contact name
- Clinical Trial Unit IBIS/University Hospital Virgen del Rocío
Public contact point
- Organisation
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Contact name
- Clinical Trial Unit IBIS/University Hospital Virgen del Rocío
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 240 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Virgen De La Macarena
Neurology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
University Hospital Virgen Del Rocio S.L.
Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
University Clinical Hospital Virgen De La Arrixaca
Radiodiagnosis and Breast Cancer, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario Reina Sofia
Radiodiagnosis and Breast Cancer, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Y Politecnico La Fe
Neurology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario De Cruces
Neurology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitari De Girona Doctor Josep Trueta
Neurointervention Service, Avinguda De Franca S/n, 17007, Girona
Hospital General Universitario Dr. Balmis
Radiodiagnosis Service - Interventional Neuroradiology Unit, Avinguda Del Pintor Baeza 12, 03010, Alicante
Complejo Hospitalario Torrecárdenas (Almería, SPAIN)
Neurology, Avenida Torrecardenas, S/N
Complexo Hospitalario Universitario A Coruña (La Coruña, Spain)
Radiodiagnosis, Diagnostic and Interventional Neuroradiology Area, Avenida del Pasaje, 82D
Complejo Hospital Universitario De Badajoz (Badajoz, SPAIN)
Neurology, Av. de Elvas, s/n
Hospital Ramón y Cajal (Madrid, SPAIN)
Radiology, Calle de Manuel Tovar 23, 28034
Hospital Germans Trias I Pujol
Neurology, Carretera Canyet 1a Planta, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Spain | 2022-05-01 | 2026-03-20 | 2022-05-01 | 2025-12-30 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-27 | Spain | Acceptable 2024-04-30
|
2024-04-30 |