NCT06853535RecruitingPhase 3
Precision Antiplatelet Therapy Guided by Platelet Aggregation Function in Patients With Acute Ischemic STROKE
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
The objective of this clinical trial is to evaluate the efficacy and safety of platelet aggregation function - guided precision anti - platelet therapy in patients with acute cerebral infarction. The main question it aims to answer is: among the cerebral infarction patients with possible clopidogrel resistance detected by platelet aggregation function tests, what is the efficacy and safety of using ticagrelor to replace the clopidogrel treatment regimen.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 5138 (estimated)
- First submitted
- 18 Feb 2025
- Start date
- 23 May 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Sichuan Provincial People's Hospital
- Diseases
- Stroke
- NCT number
- NCT06853535
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 5138
- From 23 May 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received intravenous thrombolysis, intra-arterial thrombolysis, mechanical thrombectomy, or any revascularization surgery after the current onset, or plan to receive such procedures within 90 days.
- Use of heparin or oral anticoagulants within 10 days prior to enrollment.
Other illness
- Imaging examinations suggestive of hemorrhagic stroke, hemorrhagic transformation, or other pathological cerebral disorders, such as vascular malformation, tumor, abscess, or other common non-ischemic cerebral diseases (e.g., multiple sclerosis).
- Minor stroke/TIA induced by angioplasty or vascular surgery.
- Routine electrocardiogram (ECG) suggestive of atrial fibrillation (AF), or physical examination findings of typical AF signs including completely irregular cardiac rhythm, variable intensity of the first heart sound, and pulse deficit.
- Having definite indications for anticoagulant therapy (suspected cardiogenic embolism, e.g., atrial fibrillation, known artificial heart valve, suspected endocarditis, etc.).
- History of gastrointestinal bleeding, intracranial hemorrhage, massive hemorrhage or blood transfusion in the recent period (excluding mild hemoptysis and mild abnormal vaginal bleeding), or history of other hemorrhagic diseases caused by coagulation dysfunction (e.g., purpura).
- Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency, and those with severe comorbidities (e.g., malignancy, chronic airflow limitation, severe dementia, severe heart failure).
Lab values
- Having contraindications to or intolerance of clopidogrel, ticagrelor, or aspirin, including:
- Known history of hypersensitivity;
- Severe hepatic or renal insufficiency (definition of severe hepatic insufficiency: ALT \> 2× upper limit of normal \[ULN\] or AST \> 2× ULN; definition of severe renal insufficiency: creatinine \> 1.5× ULN);
- Severe heart failure (NYHA Class Ⅲ or Ⅳ);
- Coagulation disorders or history of systemic hemorrhage;
- History of previous thrombocytopenia or neutropenia;
- History of previous drug-induced hematological diseases or hepatic dysfunction.
- Leukopenia (\< 2×10⁹/L) or thrombocytopenia (\< 100×10⁹/L).
Age
- Women of childbearing age with a negative pregnancy test but who refuse to adopt effective contraceptive measures; pregnant or lactating women.
Other
- Use of antiplatelet agents other than aspirin and clopidogrel (e.g., ticagrelor, prasugrel) within 7 days.
- Poor compliance, unable to cooperate with the requirements of the study.
Who the study is looking for
- Age ≥ 18 years old.
- Patients diagnosed with acute non-disabling ischaemic stroke or transient ischaemic attack (TIA) with moderate to high stroke risk in accordance with the WHO diagnostic criteria, defined as follows:
- Acute non-disabling ischaemic stroke: NIHSS score ≤ 5 at enrollment;
- TIA with moderate to high stroke risk: ABCD₂ score ≥ 4.
- Time from symptom onset ≤ 48 hours. (Definition of symptom onset time: the interval from the last time the patient was observed in a normal state to the time of co-administration of clopidogrel 300 mg and aspirin 100 mg.)
- MARADP ≥ 35% measured at 5-20 hours after the patient received antiplatelet therapy with co-administration of clopidogrel 300 mg and aspirin 100 mg within 48 hours of symptom onset.
- Written informed consent signed by the patient or their legal representative.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.