Clopidogrel Plus Aspirin in Acute Ischemic Stroke Following Thrombectomy and/or Intravenous Thrombolysis (CoPrime)

Launched by UNIVERSITY OF ALBERTA · Oct 9, 2024

Keywords

ClinConnect Summary

The CoPrime trial is investigating a new approach to prevent recurrent strokes in patients who have recently experienced an acute ischemic stroke. This type of stroke occurs when a blood vessel in the brain gets blocked, leading to brain damage due to lack of blood supply. Currently, doctors usually prescribe aspirin alone to help prevent another stroke, but this study is exploring whether adding another medication called clopidogrel could be more effective. Both aspirin and clopidogrel work by preventing blood clots, but using them together may increase the risk of bleeding, which is something the study will monitor closely.

To participate in this trial, individuals must be over 18 years old and have had a mild to moderate ischemic stroke treated with a procedure to restore blood flow. They should also have no major bleeding risks and be able to provide informed consent. Participants will be randomly assigned to receive either aspirin alone or a combination of aspirin and clopidogrel for 21 days. The study will follow them for three months to evaluate their recovery and the effectiveness of the treatments. If you or someone you know is interested, keep in mind that the trial is not yet recruiting participants, so more information will be available soon.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must be \>18 years of age at the time of randomization
• • 2. Acute non-cardioembolic ischemic stroke in the anterior circulation treated with reperfusion therapy defined as intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT)
• • 3. Time from end of acute reperfusion therapy to randomization ≤ 24 hours
• • 4. Mild to moderate deficit defined as a National Institute of Health stroke scale of ≤11 at the time of randomization
• • 5. At least one non-contrast CT scan completed post reperfusion therapy and prior to randomization without any hemorrhage (including hemorrhagic infarction) and/or contrast extravasation.
• • 6. Premorbid mRS less than or equal to 2
• • 7. Signed informed consent from the patient or legally authorized representative
• Exclusion Criteria:
• • 1. Any known disorder associated with a significantly increased risk of bleeding
• • 2. Post-reperfusion CT scan ASPECT score \<8.
• • 3. Anticoagulation is required for any indication other than DVT prophylaxis
• • 4. Evidence-based indication for dual antiplatelet therapy
• • 5. Planned surgical intervention in the next 90 days includes but is not limited to carotid endarterectomy, where dual antiplatelet is not indicated, and carotid stenting, where single antiplatelet is not used.
• • 6. History of intracranial or subarachnoid hemorrhage
• • 7. Intracranial tumour, arteriovenous malformation or aneurysm;
• • 8. Intracranial or spinal cord surgery within three months;
• • 9. Gastrointestinal or urinary tract hemorrhage within the previous 21 days;
• • 10. Coagulation disorder, thrombocytopenia \<100, 000/mm3, and Prothrombin time INR ≥1.8
• • 11. Index stroke is caused by infective endocarditis, dissection, systematic or central nervous system vasculitis
• • 12. History of active malignancy being treated or life expectancy ≤ 90 days
• • 13. Allergy to clopidogrel or aspirin
• • 14. Pregnancy
• • 15. Participation in another clinical trial.
• • 16. The presence of a major co-morbid illness that would make it unlikely that the participant will be able to complete follow-up