Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT05910125

Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Guangzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Anticipated life expectancy < 3 months.
  • Pregnant or lactating women.
  • Participation in other clinical trials.
  • 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).

Treatment and study plan

Aspirin

Drug

See arm/group descriptions.

clopidogrel

Drug

See arm/group descriptions.

alteplase

Drug

See arm/group descriptions.

Primary outcomes

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

    Time frame: 90(±7) days

    The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days.

Secondary outcomes

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

    Time frame: 7(±1) days

    The proportion of the modified Rankin Scale score (mRS) 0-1 at 7 days or discharge (whichever occurred first).

  2. Early neurological deterioration

    Time frame: 7(±1) days

    The incidence of early neurological deterioration at 7 days.

  3. Recurrent stroke

    Time frame: 90(±7) days

    The incidence of recurrent stroke at 90 days.

Other outcomes

  1. SAFETY OUTCOME: Symptomatic intracranial hemorrhage

    Time frame: 24 (±12) hours

    Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria)

  2. SAFETY OUTCOME: Mortality

    Time frame: 90(±7) days

    Mortality at 90 days

  3. SAFETY OUTCOME: Any intracranial hemorrhage

    Time frame: 24 (±12) hours

    Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria)

Study contacts

Contact information is provided by the study sponsor or research team.

Yamei Tang

CONTACT

[email protected]

86-20-81332619

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: AGREE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

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.

Published trials that share one or more normalized conditions with this study.