FindTrial
Sign In

Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00221104
Enrollment
1578
Registered
2005-09-22
Start date
2004-03-01
Completion date
Unknown
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

stroke, brain ischemia, cerebrovascular accident, statin, hydroxymethylglutaryl-CoA reductase inhibitors, cholesterol, hypercholesterolemia, hyperlipidemia, multicenter studies, prospective studies, endpoint determination, randomized controlled trials, recurrence, pravastatin

Brief 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.

Interventions

DRUGPravastatin

Sponsors

Ministry of Health, Labour and Welfare, Japan
CollaboratorOTHER_GOV
Hiroshima University
CollaboratorOTHER
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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 \<=100,000/ul within 3 months prior to study start * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>= 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence Rate of Stroke and TIAup to 5 yearsIncidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

Secondary

MeasureTime frameDescription
Incidence Rate of Atherothrombotic Infarctionup to 5 yearsIncidence rate of patients with atherothrombotic infarction
Incidence Rate of Lacunar Infarctionup to 5 yearsIncidence rate of patients with lacunar infarction
Incidence Rate of Cardioembolic Infarctionup to 5 yearsIncidence rate of patients with cardioembolic infarction
Incidence Rate of Intracranial Hemorrhageup to 5 yearsIncidence rate of patients with intracranial hemorrhage

Countries

Japan

Participant flow

Recruitment details

Participants were enrolled from March 2004 and February 2009 recruited at 123 clinical sites in Japan

Pre-assignment details

Participants were randomly assigned to the pravastatin group or the control with 1:1 allocation rate. The patient allocation was dynamically balanced with the stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence) between the two groups.

Participants by arm

ArmCount
Pravastatin
The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
793
Control Group
The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
785
Total1,578

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event10
Overall StudyOthers3747
Overall StudyPhysician Decision10
Overall StudyProtocol Violation20
Overall StudyWithdrawal by Subject4229

Baseline characteristics

CharacteristicControl GroupTotalPravastatin
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
456 Participants914 Participants458 Participants
Age, Categorical
Between 18 and 65 years
329 Participants664 Participants335 Participants
Diabetes mellitus
No
601 participants1209 participants608 participants
Diabetes mellitus
Yes
184 participants369 participants185 participants
High blood pressure
No
476 participants961 participants485 participants
High blood pressure
Yes
309 participants617 participants308 participants
Ischemic stroke subtype
Atherothrombotic infarction
206 participants401 participants195 participants
Ischemic stroke subtype
Infarction of undetermined etiology
75 participants171 participants96 participants
Ischemic stroke subtype
Lacunar infarction
504 participants1006 participants502 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
785 Participants1578 Participants793 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
Japan
785 participants1578 participants793 participants
Sex: Female, Male
Female
243 Participants491 Participants248 Participants
Sex: Female, Male
Male
542 Participants1087 Participants545 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
188 / 780164 / 785

Outcome results

Primary

Incidence Rate of Stroke and TIA

Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

Time frame: up to 5 years

Population: intention to treat

ArmMeasureValue (NUMBER)
PravastatinIncidence Rate of Stroke and TIA2.56 events /100 person-years
Control GroupIncidence Rate of Stroke and TIA2.65 events /100 person-years
Comparison: the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)p-value: 0.823495% CI: [0.73, 1.29]Stratified log-rank test
Secondary

Incidence Rate of Atherothrombotic Infarction

Incidence rate of patients with atherothrombotic infarction

Time frame: up to 5 years

Population: intention to treat

ArmMeasureValue (NUMBER)
PravastatinIncidence Rate of Atherothrombotic Infarction0.65 events /100 person-years
Control GroupIncidence Rate of Atherothrombotic Infarction0.21 events /100 person-years
Comparison: the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)p-value: 0.004795% CI: [0.15, 0.74]Stratified log-rank test
Secondary

Incidence Rate of Cardioembolic Infarction

Incidence rate of patients with cardioembolic infarction

Time frame: up to 5 years

Population: intention to treat

ArmMeasureValue (NUMBER)
PravastatinIncidence Rate of Cardioembolic Infarction0.18 events /100 person-years
Control GroupIncidence Rate of Cardioembolic Infarction0.08 events /100 person-years
Comparison: the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)p-value: 0.198695% CI: [0.61, 9.14]Stratified log-rank test
Secondary

Incidence Rate of Intracranial Hemorrhage

Incidence rate of patients with intracranial hemorrhage

Time frame: up to 5 years

Population: intention to treat

ArmMeasureValue (NUMBER)
PravastatinIncidence Rate of Intracranial Hemorrhage0.29 events /100 person-years
Control GroupIncidence Rate of Intracranial Hemorrhage0.31 events /100 person-years
Comparison: the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)p-value: 0.995395% CI: [0.45, 2.22]Stratified log-rank test
Secondary

Incidence Rate of Lacunar Infarction

Incidence rate of patients with lacunar infarction

Time frame: up to 5 years

Population: intention to treat

ArmMeasureValue (NUMBER)
PravastatinIncidence Rate of Lacunar Infarction1.26 events /100 person years
Control GroupIncidence Rate of Lacunar Infarction1.01 events /100 person years
Comparison: the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)p-value: 0.307595% CI: [0.81, 1.91]Stratified log-rank test

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026