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Completed

NCT Number: NCT06638151

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • The presence of a major co-morbid illness that would make it unlikely that the participant will be able to complete follow-up

Treatment and study plan

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).

Other names: Dual antiplatelet treatment

Aspirin

Drug

Aspirin 81 mg once daily alone

Primary outcomes

  1. Safety

    Time frame: 90 days

    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.

  2. Feasibility

    Time frame: 21 days

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

Secondary outcomes

  1. Early Neurological Deterioration

    Time frame: 7 days

    Secondary outcome measures include the proportion of patients with worsening focal neurologic deficit by NIHSS ≥4 at day seven or discharge not due to hemorrhagic transformation or any intracranial hemorrhage. Worsening will be defined as a change in NIHSS compared to NIHSS at the time of randomization.

  2. Recurrent Stroke

    Time frame: 90 days

  3. Death

    Time frame: 90 days

  4. Non-Stroke Thrombotic events

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

Clopidogrel Plus Aspirin in Acute Ischemic Stroke Following Thrombectomy and/or Intravenous Thrombolysis (CoPrime): A Randomized Pilot Study

Acronym: CoPrime

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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