Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 28, 2024

Interventions

  • Drug: Aspirin 100mg; Clopidogrel 300mg
    • Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization

Arms, Groups and Cohorts

  • Experimental: double antiplatelet group
    • aspirin 100mg plus clopidogrel 300mg
  • Placebo Comparator: control group
    • aspirin placebo plus clopidogrel placebo

Clinical Trial Outcome Measures

Primary Measures

  • The proportion of excellent prognosis
    • Time Frame: 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 Measures

  • The proportion of favorable prognosis
    • Time Frame: Day 90
    • Favorable 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.
  • Distribution of modified Rankin Score (mRS)
    • Time Frame: 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)
    • Time Frame: 24 hours, 48 hours, and 2 weeks
    • the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
  • symptomatic intracerebral hemorrhage
    • Time Frame: 36 hours
    • any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
  • any intracerebral hemorrhage
    • Time Frame: 36 hours
    • the evidence of bleeding on the head CT or MRI scan
  • the incidence of stroke recurrence and other vascular events
    • Time Frame: Day 90
  • the death due to any cause
    • Time Frame: Day 90

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • General Hospital of Shenyang Military Region
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hui-Sheng Chen, Head of Neurology – General Hospital of Shenyang Military Region

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.