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CompletedNCT05193071Updated Oct 31, 2024

Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

A Phase 4 interventional study of Aspirin 100mg; Clopidogrel 300mg in Ischemic Stroke, sponsored by General Hospital of Shenyang Military Region. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by General Hospital of Shenyang Military Region · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,022
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • thrombolysis
  • minor stroke
  • early antiplatelet
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 1,022 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,022 participants (actual)

Study arms

  • Experimental
    double antiplatelet group

    aspirin 100mg plus clopidogrel 300mg

    Drug: Aspirin 100mg; Clopidogrel 300mg

  • Placebo comparator
    control group

    aspirin placebo plus clopidogrel placebo

    Drug: Aspirin 100mg; Clopidogrel 300mg

Interventions

  • DrugAspirin 100mg; Clopidogrel 300mg

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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. The incidence of any intracerebral hemorrhage

    the evidence of bleeding on the head CT or MRI scan

    Time frame: 36 hours

  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

07

Study locations

2 sites
  • Hui-sheng Chen
    ShenYang, None Selected 110840, China
  • Department of Neurology, General Hospital of Northern Theater Command
    Shenyang, 110016, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05193071
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (Head of Neurology, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Jan 14, 2022
Start date
Jul 8, 2022
Primary completion
Oct 25, 2024
Completion
Oct 25, 2024
Last update
Oct 31, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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