Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

Ischemic Stroke Clinical Trial

— AGREE  

Official title:

Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05910125
• Other study ID #: SYSKY-2022-252-02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2023
• Est. completion date: July 2027

Study information

• Verified date: June 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yamei Tang
• Phone: 86-20-81332619
• Email: tangym[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 472
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Aspirin
See arm/group descriptions.
• Clopidogrel
See arm/group descriptions.
• Alteplase
See arm/group descriptions.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	SAFETY OUTCOME: Symptomatic intracranial hemorrhage	Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria)	24 (±12) hours
Other	SAFETY OUTCOME: Mortality	Mortality at 90 days	90(±7) days
Other	SAFETY OUTCOME: Any intracranial hemorrhage	Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria)	24 (±12) hours
Primary	The modified Rankin Scale score (mRS) 0-1	The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days.	90(±7) days
Secondary	The modified Rankin Scale score (mRS) 0-1	The proportion of the modified Rankin Scale score (mRS) 0-1 at 7 days or discharge (whichever occurred first).	7(±1) days
Secondary	Early neurological deterioration	The incidence of early neurological deterioration at 7 days.	7(±1) days
Secondary	Recurrent stroke	The incidence of recurrent stroke at 90 days.	90(±7) days