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Acute Ischemic StrokePhase 2CoPrimeNCT06638151

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

A Phase 2 study testing aspirin + clopidogrel and Aspirin in people with Acute Ischemic Stroke, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
aspirin + clopidogrel and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteCanada
Study dates
2 Sep 2025to 13 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta Hospital

    Edmonton, Alberta, T6G2B7

Other trials in Canada

About this study

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

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.

Being tested
aspirin + clopidogrel, Aspirin
Keywords
intravenous thrombolysis, endovascular thrombectomy, recurrent stroke, Anti-platelet Medication, Aspirin, Clopidogrel, Acute ischemic stroke
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aspirin + clopidogrelDrug

    Also called Dual antiplatelet treatment

    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).

  • AspirinDrug

    Aspirin 81 mg once daily alone

Study groups in NCT06638151
Study groupRoleWhat they receive
Aspirin GroupActive comparatorNot described
Receives: Drug: Aspirin
Dual Antiplatelet GroupExperimentalNot described
Receives: Drug: aspirin + clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90 days

  2. Feasibility

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

    Measured: 21 days

Secondary outcomes (4)

  1. Early Neurological Deterioration

    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.

    Measured: 7 days

  2. Recurrent Stroke

    Measured: 90 days

  3. Death

    Measured: 90 days

  4. Non-Stroke Thrombotic events

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start2 Sep 2025
  3. Primary completion13 Jul 2026
  4. Study completion13 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06638151
Sponsor's protocol ID
Pro00140876
Acronym
CoPrime
Status last verified
Jul 2026
First submitted
4 Oct 2024
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be available to investigators in consultation with the principal investigators

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aspirin + clopidogrel and Aspirin in people with Acute Ischemic Stroke, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06638151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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