Phase 3
N=1,578
Japan Statin Treatment Against Recurrent Stroke (J-STARS)
Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00221104 ↗Enrolled (actual)
1,578
Serious AEs
22.5%
Results posted
Jan 2018
Primary outcome: Primary: Incidence Rate of Stroke and TIA — 2.56; 2.65 events /100 person-years — p=0.8234
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pravastatin (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Stroke and TIA |
2.56; 2.65 | 0.8234 |
| SECONDARY Incidence Rate of Atherothrombotic Infarction |
0.65; 0.21 | 0.0047 sig |
| SECONDARY Incidence Rate of Lacunar Infarction |
1.26; 1.01 | 0.3075 |
| SECONDARY Incidence Rate of Cardioembolic Infarction |
0.18; 0.08 | 0.1986 |
| SECONDARY Incidence Rate of Intracranial Hemorrhage |
0.29; 0.31 | 0.9953 |
Summary
Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.
Eligibility Criteria
Inclusion Criteria
- Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
- Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
- Able to visit outpatient department
- Informed consent on the form.
Exclusion Criteria
- Ischemic stroke of other determined cause according to the TOAST classification
- Ischemic heart disease and necessary to use statin
- Hemorrhagic disorders
- Platelet count = 100IU/L within 3 months prior to study start
- Serum creatinine >=2.0mg/dl within 3 months prior to study start
- A scheduled operation
- The presence of malignant disorder
Data sourced from ClinicalTrials.gov (NCT00221104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.