Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

Phase 4CompletedNCT05193071

General Hospital of Shenyang Military Region1,022 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,022

Conditions

Ischemic Stroke

Interventions

Aspirin 100mg; Clopidogrel 300mgDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Hui-sheng Chen

Shenyang, None Selected, China

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China

Outcomes

Primary Outcomes

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

Time frame: Day 90

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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)

Time frame: 36 hours

The incidence of any intracerebral hemorrhage

the evidence of bleeding on the head CT or MRI scan

Data from ClinicalTrials.gov

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