Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke

Phase

Condition

Stroke

Cardiac Ischemia

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT02869009

k2016-06

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 renaldysfunction)
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 plateletfunction
Anticoagulation within 10 days
Gastrointestinal bleed or major surgery within 3 months
Planned or likely revascularization (any angioplasty or vascular surgery) within thenext 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 ofenrollment
Severe noncardiovascular comorbidity with life expectancy <3 months

Study Design

November 01, 2016

October 31, 2022

Study Description

The ATAMIS study is a multicentre, prospective, randomised, open-label, controlled trial with a target enrollment of 3,000 patients from 60 centres of the Northeast China. Eligible patients are as follows: (1) definite acute ischemic stroke; (2) neurological deficit: 4 ≤ NIHSS ≤ 10; (3) time from onset to drug treatment: within 48 hours.

Patients in the clopidogrel-aspirin group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 75 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.

Patients in the aspirin-alone group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.

The primary efficacy end point is early neurological deterioration assessed as a change of NIHSS: no change of NIHSS within 14 days.

Connect with a study center

General Hospital of Shenyang Military Region
Shenyang, Liaoning
China
Site Not Available

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