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Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

G

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase

Completed
Phase 4

Conditions

Ischemic Stroke

Treatments

Drug: Aspirin 100mg; Clopidogrel 300mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05193071
y (2021) 109

Details and patient eligibility

About

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.

Enrollment

1,022 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,022 participants in 2 patient groups, including a placebo group

double antiplatelet group
Experimental group
Description:
aspirin 100mg plus clopidogrel 300mg
Treatment:
Drug: Aspirin 100mg; Clopidogrel 300mg
control group
Placebo Comparator group
Description:
aspirin placebo plus clopidogrel placebo
Treatment:
Drug: Aspirin 100mg; Clopidogrel 300mg

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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