Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

Study Overview
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Brief Summary
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The current guideline recommends to give antithrombotic treatment 24 hours after intravenous thrombolysis in acute ischemic stroke. However, early neurological deterioration will occur in some patients due to no antithrombotic treatment, which is closely associated with poor outcome. The current trial aims to investigate the effectiveness and safety of early antithrombotic treatment after intravenous thrombolysis in minor stroke.

Official Title
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Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST): a Prospective, Random, Double Blinded and Multi-center Study

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Aspirin 100mg; Clopidogrel 300mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old; Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset; NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination; Premorbid mRS ≤ 1; Signed informed consent. Exclusion Criteria: Premorbid mRS≥2; Uncontrolled severe hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg after drug treatment); Antithrombotic treatment within 24 hours before randomization; Significant dysphagia and inability to take the experimental drug orally; Allergy or contraindication to study drugs; Comorbidity with any serious diseases and life expectancy is less than half a year; Participating in other clinical trials within three months; Patients not suitable for this clinical study considered by researcher

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: double antiplatelet group<br>aspirin 100mg plus clopidogrel 300mg | Drug: Aspirin 100mg; Clopidogrel 300mg<br>* Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization<br>|
| Placebo Comparator: control group<br>aspirin placebo plus clopidogrel placebo | Drug: Aspirin 100mg; Clopidogrel 300mg<br>* Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of excellent prognosis | excellent prognosis is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of favorable prognosis | Favorable prognosis is defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome. | Day 90 | 
| Distribution of modified Rankin Score (mRS) | The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome. | Day 90 | 
| Changes in National Institute of Health stroke scale (NIHSS) | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome. | 24 hours, 48 hours, and 10 days | 
| Occurrence of early neurologyical deterioration (END) | END is defined as more than 2 point increase, but not result of cerebral hemorrhage, compared with baseline at 24 hours | 24 hours | 
| The incidence of symptomatic intracerebral hemorrhage | any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase) | 36 hours | 
| The incidence of any intracerebral hemorrhage | the evidence of bleeding on the head CT or MRI scan | 36 hours | 
| The incidence of stroke recurrence and other vascular events |  | Day 90 | 
| The death due to any cause |  | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thrombolysis, minor stroke, early antiplatelet