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

NCT06638151 | Recruiting Phase 2

• 1 other identifier: Pro00140876
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

intravenous thrombolysis; endovascular thrombectomy; recurrent stroke; Anti-platelet Medication; Aspirin; Clopidogrel; Acute ischemic stroke

Outcome Measures

Primary Outcomes (2)

• Safety

  Safety will be assessed as a proportion of patients with symptomatic hemorrhagic transformation, defined as worsening of NIHSS ≥4 compared to NIHSS at the time of randomization and hemorrhage is attributable to the antiplatelet therapy by the treatment team.

  90 days

• Feasibility

  Feasibility will be assessed as a proportion of recruited patients complete the study intervention for 21 days.

  21 days

Secondary Outcomes (4)

• Early Neurological Deterioration

  7 days

• Recurrent Stroke

  90 days

• Death

  90 days

• Non-Stroke Thrombotic events

  90 days

Study Arms (2)

Aspirin Group

ACTIVE COMPARATOR

Drug: Aspirin

Dual Antiplatelet Group

EXPERIMENTAL

Drug: aspirin + clopidogrel

Interventions

aspirin + clopidogrel DRUG

Enrolled patients with acute ischemic stroke will be randomly assigned to the clopidogrel plus aspirin group (300 mg loading dose of clopidogrel plus 160 mg aspirin on day 1; followed by clopidogrel 75 mg plus aspirin 81 mg daily from day 2-day 21, followed by aspirin 81 mg to be continued if no alternate treatment is indicated).

Also known as: Dual antiplatelet treatment

Dual Antiplatelet Group

Aspirin DRUG

Aspirin 81 mg once daily alone

Aspirin Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be \>18 years of age at the time of randomization
• Acute non-cardioembolic ischemic stroke in the anterior circulation treated with reperfusion therapy defined as intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT)
• Time from end of acute reperfusion therapy to randomization ≤ 24 hours
• Mild to moderate deficit defined as a National Institute of Health stroke scale of ≤11 at the time of randomization
• 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.
• Premorbid mRS less than or equal to 2
• Signed informed consent from the patient or legally authorized representative

You may not qualify if:

• Any known disorder associated with a significantly increased risk of bleeding
• Post-reperfusion CT scan ASPECT score \<8.
• Anticoagulation is required for any indication other than DVT prophylaxis
• Evidence-based indication for dual antiplatelet therapy
• 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.
• History of intracranial or subarachnoid hemorrhage
• Intracranial tumour, arteriovenous malformation or aneurysm;
• Intracranial or spinal cord surgery within three months;
• Gastrointestinal or urinary tract hemorrhage within the previous 21 days;
• Coagulation disorder, thrombocytopenia \<100, 000/mm3, and Prothrombin time INR ≥1.8
• Index stroke is caused by infective endocarditis, dissection, systematic or central nervous system vasculitis
• History of active malignancy being treated or life expectancy ≤ 90 days
• Allergy to clopidogrel or aspirin
• Pregnancy
• Participation in another clinical trial.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Brian Buck

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Mahesh Kate

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Sugars

CONTACT

7804074366; esugars@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: September 2, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CA (1)