Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Stroke

Treatments: Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin; Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00664846

2006BAI01A10-1

Details and patient eligibility

About

The purposes of the study are to analyse the cross-section data of secondary stroke prevention in China and to carry out a standard medical management including medicine and interactive education program,and to evaluate the efficacy and safety of the standard medical management in secondary stroke prevention.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ischemic cerebral infarction or TIA within 30 days.
2. Aged above 18 years old.
3. Hospitalized.
4. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
5. Stable clinical and neurological conditions.
6. A Modified Rankin score less than 4 at enrollment
7. Informed consent is obtained.

Exclusion criteria

Patients will be excluded from entry if any of the criteria listed below are met

1. Documented stroke caused by conditions other than atherosclerosis, ie, surgical or vascular intervention procedure.
2. Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years
3. Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
4. A Modified Rankin score is more than 4
5. Concurrent participation in another clinical trial
6. Pregnant
7. Unable to give informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,000 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Aspirin / Clopidogrel, Atorvastatin / Simvastatin

2

Active Comparator group

Treatment:

Drug: Asprin / Clopidogrel, Atorvastatin / Simvastatin