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NCT Number: NCT07644234

Platelet Aggregation Function-Guided De-Escalation Antiplatelet Therapy in Patients With Acute Ischemic Stroke

This multicenter, prospective, open-label, randomized controlled trial will evaluate whether platelet aggregation function-guided de-escalation of antiplatelet therapy is non-inferior in efficacy and superior in safety compared with standard dual antiplatelet therapy in patients with acute minor ischemic stroke or high-risk transient ischemic attack who are sensitive to clopidogrel.

Participants who present within 48 hours of symptom onset and meet the eligibility criteria will receive loading doses of clopidogrel and aspirin, followed by platelet aggregation function testing. Eligible clopidogrel-sensitive participants will be randomized to receive either 7 days of dual antiplatelet therapy followed by clopidogrel monotherapy or standard 21-day dual antiplatelet therapy followed by single antiplatelet therapy. The primary efficacy outcome is new stroke within 90 days after randomization.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location contact

Jie Yang Deputy Director of the Department of Neurology

CONTACT

[email protected]

+86 13678130516

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Age 18 years or older. 2.Diagnosis of acute non-disabling ischemic stroke or transient ischemic attack according to World Health Organization criteria, meeting one of the following definitions: acute non-disabling ischemic stroke, defined as a National Institutes of Health Stroke Scale score of 5 or lower at enrollment; or high-risk transient ischemic attack, defined as an ABCD2 score of 4 or higher.

3.Symptom onset within 48 hours. Onset time is defined as the interval from the last time the participant was known to be well to the time of combined administration of clopidogrel 300 mg and aspirin 100 mg.

4.MARADP <35% measured 5 to 20 hours after combined antiplatelet treatment with clopidogrel 300 mg and aspirin 100 mg within 48 hours of symptom onset.

5.Planned treatment with aspirin plus clopidogrel or clopidogrel monotherapy for antiplatelet therapy.

6.Written informed consent provided by the participant or a legally authorized representative.

Exclusion criteria

1.Imaging evidence of hemorrhagic stroke, hemorrhagic transformation, or another pathological brain disorder, such as vascular malformation, tumor, abscess, or another common non-ischemic brain disease such as multiple sclerosis.

2.Minor stroke or transient ischemic attack caused by angioplasty or vascular surgery.

3.Atrial fibrillation indicated by standard electrocardiography or typical physical signs of atrial fibrillation, including absolutely irregular rhythm, variable intensity of the first heart sound, or pulse deficit.

4.A clear indication for anticoagulation, including suspected cardioembolism such as atrial fibrillation, known artificial heart valve, or suspected endocarditis.

5.Intravenous thrombolysis, intra-arterial thrombolysis, mechanical thrombectomy, or any revascularization procedure performed after the index event or planned within 90 days.

6.Use of antiplatelet agents other than aspirin or clopidogrel within 7 days before enrollment, such as ticagrelor or prasugrel.

7.History of gastrointestinal bleeding, intracranial hemorrhage, recent major bleeding or blood transfusion, excluding minor hemoptysis or minor abnormal vaginal bleeding, or other bleeding disorder caused by coagulation dysfunction, such as purpura.

8.Contraindication or intolerance to clopidogrel or aspirin, including known allergy; severe hepatic insufficiency or renal insufficiency; severe heart failure; coagulation disorder or history of systemic bleeding; history of thrombocytopenia or neutropenia; or history of drug-induced hematologic disease or hepatic dysfunction.

9.Leukopenia, defined as white blood cell count <2 x 10^9/L, or thrombocytopenia, defined as platelet count <100 x 10^9/L.

10.Use of heparin or oral anticoagulants within 10 days before enrollment. 11.Severe cardiac, pulmonary, hepatic, or renal dysfunction, or severe comorbid disease such as tumor, chronic airflow disease, severe dementia, or severe heart failure.

12.Female participants of childbearing potential with a negative pregnancy test who refuse to use effective contraception, or women who are pregnant or breastfeeding.

13.Poor compliance or inability to complete study requirements.

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Treatment and study plan

clopidogrel

Drug

Clopidogrel will be administered according to the assigned antiplatelet strategy. Participants receive a loading dose during screening and then clopidogrel 75 mg orally once daily during the assigned treatment period.

Aspirin

Drug

Aspirin will be administered according to the assigned antiplatelet strategy. Participants receive aspirin during screening and then aspirin 100 mg orally once daily during the assigned treatment period.

Primary outcomes

  1. Recurrent stroke (including ischemic and hemorrhagic stroke) within 90 days

    Time frame: within 90 days

Secondary outcomes

  1. New stroke at prespecified follow-up visits

    Time frame: At Day 7 or hospital discharge, Day 30 and 1 year after randomization

  2. New vascular events

    Time frame: At Day 7 or hospital discharge, Day 30, Day 90, and 1 year after randomization

    Including cardiovascular and cerebrovascular strokes, myocardial infarctions, and vascular deaths.

  3. Modified Rankin Scale score

    Time frame: At Day 30, Day 90, 1 year, and 2 years after randomization

    The score range of the scale is from 0 to 6. The higher the score, the worse the outcome.

  4. New ischemic stroke

    Time frame: At Day 7 or hospital discharge, Day 30, Day 90, and 1 year after randomization

  5. Worsening of nerve damage (an increase in the NIHSS score by ≥ 4 points compared to the baseline)

    Time frame: At 24 hours and at Day 7 or hospital discharge after randomization

  6. Quality of life at day 90 [assessed by the EuroQol - 5 dimension (EQ - 5D) questionnaire]

    Time frame: At Day 90 after randomization

    It is usually represented by a value between 0 and 1, where 1 represents perfect health, 0 represents death, and the intermediate values reflect different degrees of health status.

Study contacts

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

Jie Yang Deputy Director of the Department of Neurology

CONTACT

[email protected]

+8613678130516

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Acronym: PATH STROKE D

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

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.

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