Clopidogrel + Aspirin for Stroke
(CoPrime Trial)

Recruiting in Palo Alto (17 mi)

Brian BUCK | Professor (Associate) | MD ...

Overseen byMahesh Kate

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Alberta

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?Stroke is a common cause of disability. The most common type of stroke, an ischemic stroke, is caused by a blood vessel in the brain getting blocked by a clot. When this happens, part of the brain is damaged because it is not getting the blood supply it needs. To treat this type of stroke, doctors give medication and/or do a procedure to remove the blockage and restore blood supply to the brain. Unfortunately, patients who have had an ischemic stroke are at higher risk of having another ischemic stroke. This risk is highest in the first 21 days after a stroke. Currently, doctors give patients the medication aspirin every day, starting 24 hours after stroke treatment, to prevent recurrent strokes. However, some studies have shown that giving another medication, clopidogrel, in addition to aspirin, is safe and may work better than aspirin alone at preventing repeat strokes. Both aspirin and clopidogrel are a type of medication called an antiplatelet that prevents clots from forming in the blood. When both medications are given together, it is called dual antiplatelet treatment. The main risk of antiplatelet medications is bleeding. This research aims to study the safety and feasibility of using dual antiplatelet treatment to prevent recurrent strokes. Patients who have received treatment for an ischemic stroke will first be screened to rule out patients at high risk of bleeding. Following informed consent, patients at low risk of bleeding will be enrolled in the study 24 hours after their initial stroke treatment. Patients will be randomly assigned to either take aspirin alone or aspirin and clopidogrel for 21 days for recurrent stroke prevention. The study team will then follow patients for three months after treatment to collect information about their recovery and assess differences between the two groups.

Eligibility Criteria

This trial is for patients who've had an ischemic stroke and have been treated with thrombectomy or IV thrombolysis. They must be at low risk of bleeding to participate, as determined by screening after their initial treatment.

Inclusion Criteria

I was enrolled in the study within 24 hours after my clot removal treatment.

Signed informed consent from the patient or legally authorized representative

Mild to moderate deficit defined as a National Institute of Health stroke scale of less than or equal to 11 at the time of randomization

+4 more

Exclusion Criteria

I have not had bleeding in my stomach, intestines, or urinary tract in the last 3 weeks.

My brain scan score after treatment is below 8.

Participation in another clinical trial

+13 more

Participant Groups

The CoPrime study tests if taking aspirin plus clopidogrel (dual antiplatelet treatment) is safer and more effective than just aspirin in preventing another stroke within the first 21 days post-treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: Dual Antiplatelet GroupExperimental Treatment1 Intervention

Group II: Aspirin GroupActive Control1 Intervention

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

🇪🇺 Approved in European Union as Aspirin for: