Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

NCT ID: NCT05910125

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2027-07-31

Brief Summary

An open-label, blinded endpoint, randomized controlled trial that includes patients diagnosed with non-disabling, non-large vessel occlusion, acute minor stroke within 4.5 hours of onset. Eligible participants would be randomly assigned to the thrombolysis group (intravenous alteplase) and the dual antiplatelet group (oral aspirin plus clopidogrel). The primary outcome is the proportion of the excellent functional outcome (modified Rankin scale 0-1) at 90 days.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DAPT group

Receiving dual antiplatelet therapy immediately after randomization (Oral aspirin 100mg+clopidogrel 300mg, Day 1). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90) and clopidogrel 75mg/d (Day 2-21), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs.

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

See arm/group descriptions.

Clopidogrel

Intervention Type: DRUG

See arm/group descriptions.

IVT group

Receiving intravenous thrombolysis immediately after randomization (Intravenous alteplase, 0.9mg/kg, a maximum dosage of 90mg). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs.

Group Type: ACTIVE_COMPARATOR

Alteplase

Intervention Type: DRUG

See arm/group descriptions.

Interventions

Aspirin

See arm/group descriptions.

Intervention Type: DRUG

Clopidogrel

See arm/group descriptions.

Intervention Type: DRUG

Alteplase

See arm/group descriptions.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 40-80 years.

2. Diagnosed with acute ischemic stroke, NIHSS ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness.

3. Time from symptoms onset to randomization within 4.5 hours; the onset time refers to the "Last Known Normal" (LKN).

4. Absence of large vessel occlusion on CTA.

5. Pre-stroke mRS ≤ 1.

6. Signed informed consent.

Exclusion Criteria

1. Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy.

2. Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan.

3. Acute coronary syndrome suggested by Electrocardiogram.

4. History of gastrointestinal bleeding.

5. Planned sequential IVT or endovascular treatment.

6. History of allergy to aspirin, clopidogrel, and/or alteplase.

7. Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment.

8. Blood glucose ≤ 2.7 mmol/L.

9. Epileptic seizures during a stroke attack.

10. Recent trauma (<15 days).

11. Recent intracranial or spinal cord surgery, head trauma, or stroke (<3 months).

12. History of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor.

13. Active visceral hemorrhage (<22 days).

14. History of anticoagulant use within 24 hours prior to onset.

15. Platelets <100,000, PTT > 40 seconds on heparin, or PT > 15 or INR > 1.7, or known bleeding disposition.

16. Anticipated life expectancy < 3 months.

17. Pregnant or lactating women.

18. Participation in other clinical trials.

19. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yamei Tang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Yamei Tang

Role: CONTACT

tangym@mail.sysu.edu.cn

86-20-81332619

Other Identifiers

SYSKY-2022-252-02

Identifier Type: -

Identifier Source: org_study_id