Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

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

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 Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: Aspirin 100mg; Clopidogrel 300mg

• Study Type: Interventional
• Enrollment (Actual): 1022
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shenyang, China, 110016
    • Department of Neurology, General Hospital of Northern Theater Command
  • None Selected
    • ShenYang, None Selected, China, 110840
      • Hui-Sheng Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2022
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: thrombolysis; minor stroke; early antiplatelet
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel; Aspirin
• Other Study ID Numbers: y (2021) 109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No