Using a P2Y12 inhibitor with thrombectomy for acute stroke treatment
REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts (REPERFUSE)
This study is testing if adding a specific medication to a common stroke treatment can help people recover better after having an acute ischemic stroke.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 368 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 13 sites (Besançon and 12 other locations) |
| Trial ID | NCT04667078 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intravenous cangrelor, a P2Y12 inhibitor, in combination with mechanical thrombectomy and best medical management for patients with acute ischemic stroke. The study focuses on patients who have a substantial ischemic penumbra as determined by perfusion imaging within 24 hours of symptom onset. The goal is to improve reperfusion rates and functional outcomes at three months post-treatment. By addressing the limitations of current treatments, this trial aims to enhance recovery for stroke patients who are eligible for thrombectomy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with anterior circulation large artery occlusion and specific imaging criteria indicating eligibility for mechanical thrombectomy.
Not a fit: Patients with contraindications to P2Y12 inhibitors or those who do not meet the imaging criteria for thrombectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.
How similar studies have performed: Other studies have shown promising results with P2Y12 inhibitors in similar contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age 18 or older
* Anterior circulation intracanial large artery occlusion isolated (Intracranial ICA and/or MCA) proved on CTA or MRA.
* Symptoms onset \< 24h at imaging
* Indication for MT and fulfillment of the following brain imaging criteria :
1. Perfusion imaging: An initial infarct volume (ischemic core on DWI or CTP calculated by the RAPID software) of less than 70 ml, a ratio between the critically hypoperfused lesion volume (calculated by RAPID with a TMax\>6s) and initial infarct volume of 1.8 or more, and an absolute difference between those 2 volumes of 15 ml or more.
OR (if perfusion imaging not available or uninterpretable) :
2. CORE CLINICAL MISMATCH: Core calculated on DWI by RAPID, \<25 mL if NIHSS 6-20 and \<50 mL if NIHSS\>20
OR (if RAPID results are not considered reliable by the clinician) :
3. CORE CLINICAL MISMATCH according to the clinician evaluation
* Pre-stroke mRS ≤ 2
* NIHSS ≥ 6
Exclusion Criteria:
* Contraindication to MT
* Patient over 80 years old with \>10 microbleeds on pre-treatment MRI
* Pre-existing dependency with mRS ≥3.
* Known tandem ICA-MCA occlusions requiring stenting
* ASPECT\<6 on NCCT or DWI-MRI
* Known hypersensitivity to cangrelor or to any of the excipients (mannitol, sorbitol)
* History of previous intracranial hemorrhage
* Evidence of active bleeding or acute trauma (fracture) on examination
* Recent surgery with a significant risk of bleeding
* VKA oral anticoagulation with INR \>1.7
* Curative heparin or direct oral anticoagulants (DOACs) in previous 48 hours with specific DOAC dosage ≥50 ng/ml and abnormal thrombin time for patients on dabigatran or abnormal specific anti-Xa activity for patients on apixaban, edoxaban, or rivaroxaban
* Platelet count \<100 000/ mm3
* Woman of childbearing age without a pregnancy test or with a positive serum pregnancy test
* Patient benefiting from a legal protection
* Non-membership of a national insurance scheme
* Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person
* Participation in another study regarding AIS care interfering with this study.
Where this trial is running
Besançon and 12 other locations
- CHU de Besançon — Besançon, France (Recruiting)
- Hôpital Pellegrin (CHU de Bordeaux) — Bordeaux, France (Recruiting)
- Hospices civils de Lyon, Hôpital Pierre Wertheimer — Bron, France (Recruiting)
- Hôpital Salengro (CHU Lille) — Lille, France (Recruiting)
- Hôpital Dupuytren (CHU Limoges) — Limoges, France (Recruiting)
- CHU La Timone — Marseille, France (Recruiting)
- Hôpital Central (CHU de Nancy) — Nancy, France (Recruiting)
- Hôpital Lariboisière AP-HP — Paris, France (Recruiting)
- Hôpital Pitié-Salpêtrière AP-HP — Paris, France (Recruiting)
- Hôpital Fondation A de Rothschild — Paris, France (Recruiting)
- CHU de Strasbourg — Strasbourg, France (Recruiting)
- Hôpital Foch — Suresnes, France (Recruiting)
- Hôpital Purpan (CHU de Toulouse) — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Mikael Pr MAZIGHI, Pr
- Email: mmazighi@for.paris
- Phone: 01 48 03 65 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.