Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

NCT05910125 | Not Yet Recruiting Phase 4

• 1 other identifier: SYSKY-2022-252-02
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The modified Rankin Scale score (mRS) 0-1

  7(±1) days

• Early neurological deterioration

  7(±1) days

• Recurrent stroke

  90(±7) days

Other Outcomes (3)

• SAFETY OUTCOME: Symptomatic intracranial hemorrhage

  24 (±12) hours

• SAFETY OUTCOME: Mortality

  90(±7) days

• SAFETY OUTCOME: Any intracranial hemorrhage

  24 (±12) hours

Study Arms (2)

DAPT group

EXPERIMENTAL

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.

Drug: Aspirin; Drug: Clopidogrel

IVT group

ACTIVE COMPARATOR

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.

Drug: Alteplase

Interventions

Aspirin DRUG

See arm/group descriptions.

DAPT group

Clopidogrel DRUG

See arm/group descriptions.

DAPT group

Alteplase DRUG

See arm/group descriptions.

IVT group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40-80 years.
• Diagnosed with acute ischemic stroke, NIHSS ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness.
• Time from symptoms onset to randomization within 4.5 hours; the onset time refers to the "Last Known Normal" (LKN).
• Absence of large vessel occlusion on CTA.
• Pre-stroke mRS ≤ 1.
• Signed informed consent.

You may not qualify if:

• Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy.
• Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan.
• Acute coronary syndrome suggested by Electrocardiogram.
• History of gastrointestinal bleeding.
• Planned sequential IVT or endovascular treatment.
• History of allergy to aspirin, clopidogrel, and/or alteplase.
• Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment.
• Blood glucose ≤ 2.7 mmol/L.
• Epileptic seizures during a stroke attack.
• Recent trauma (\<15 days).
• Recent intracranial or spinal cord surgery, head trauma, or stroke (\<3 months).
• History of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor.
• Active visceral hemorrhage (\<22 days).
• History of anticoagulant use within 24 hours prior to onset.
• Platelets \<100,000, PTT \> 40 seconds on heparin, or PT \> 15 or INR \> 1.7, or known bleeding disposition.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin; Clopidogrel; Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Stroke; 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; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Yamei Tang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yamei Tang

CONTACT

86-20-81332619; tangym@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

CN (1)