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NCT Number: NCT05193071

Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

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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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hui-sheng Chen, Shenyang, None Selected, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin 100mg; Clopidogrel 300mg

Drug

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

Primary outcomes

  1. 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 outcomes

  1. The proportion of favorable prognosis

    Time frame: 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.

  2. 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.

  3. Changes in National Institute of Health stroke scale (NIHSS)

    Time frame: 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.

  4. Occurrence of early neurologyical deterioration (END)

    Time frame: 24 hours

    END is defined as more than 2 point increase, but not result of cerebral hemorrhage, compared with baseline at 24 hours

  5. The incidence of 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)

  6. The incidence of any intracerebral hemorrhage

    Time frame: 36 hours

    the evidence of bleeding on the head CT or MRI scan

  7. The incidence of stroke recurrence and other vascular events

    Time frame: Day 90

  8. The death due to any cause

    Time frame: Day 90

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2022
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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