Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

Phase 4

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Aspirin 100mg; Clopidogrel 300mg

• Registration Number: NCT05193071
• Lead Sponsor: General Hospital of Shenyang Military Region

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-14
• Study Start: 2022-07-08
• Status Verified: 2024-10
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1022

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Aspirin 100mg; Clopidogrel 300mg	aspirin placebo plus clopidogrel placebo
double antiplatelet group	Aspirin 100mg; Clopidogrel 300mg	aspirin 100mg plus clopidogrel 300mg

Primary Outcome Measures

Name	Time	Method
The proportion of excellent prognosis	Day 90	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Hui-sheng Chen; 🇨🇳 ShenYang, None Selected, China

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China