Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke
China3,000 participantsStarted 2016-11
Plain-language summary
The risk of early recurrence or progression of acute ischemic stroke is very high, even in patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the dual antiplatelet treatment could reduce the risk of early recurrence or progression in patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in this group of patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Acute ischemic stroke that can be randomized within 48 hours of symptoms onset
* neurological deficit: 4 ≤ NIHSS ≤ 10
* CT or MRI scan ruling out hemorrhage or other pathology
* the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1)
* Signed informed consent by patient self or legally authorized representatives
Exclusion Criteria:
* intracranial hemorrhage and hemorrhagic cerebral infarction
* Thrombolysis for ischemic stroke
* Allergy to clopidogrel and/or aspirin
* History of stroke with serious sequelae
* Severe systemic disease (such as severe infection, severe hepatic and renal dysfunction)
* Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism)
* History of intracranial hemorrhage
* Planned treatment with nonsteroidal anti-inflammatory drugs to affect platelet function
* Anticoagulation within 10 days
* Gastrointestinal bleed or major surgery within 3 months
* Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
* Planned surgery or intervention to stop antiplatelet therapy
* Ischemic stroke induced by angiography or surgery
* Pregnancy or childbirth within the previous 4 weeks
* Patients who have been treated with any other investigational drug within 3 months of enrollment
* Severe noncardiovascular comorbidity with life expectancy \<3 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Early neurological deterioration assessed as change of NIHSS
Timeframe: 14 days
Trial details
NCT IDNCT02869009
SponsorGeneral Hospital of Shenyang Military Region