Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1022 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2024-10-25

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.

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Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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double antiplatelet group

aspirin 100mg plus clopidogrel 300mg

Group Type EXPERIMENTAL

Aspirin 100mg; Clopidogrel 300mg

Intervention Type DRUG

Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization

control group

aspirin placebo plus clopidogrel placebo

Group Type PLACEBO_COMPARATOR

Aspirin 100mg; Clopidogrel 300mg

Intervention Type DRUG

Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization

Interventions

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Aspirin 100mg; Clopidogrel 300mg

Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No