Japan Statin Treatment Against Recurrent Stroke (J-STARS) | NCT00221104

ID	Type	Description	Link
C000000207	Other Identifier	UMIN CTR

Japan Statin Treatment Against Recurrent Stroke (J-STARS) | NCT00221104 | Trialant

Sponsor/Collaborators Module

Name	Class
Ministry of Health, Labour and Welfare, Japan	OTHER_GOV
Hiroshima University	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pravastatin	Active Comparator	Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints.	Drug: Pravastatin
No intervention	No Intervention	Patient has no intervention.

Name	Type	Description	Arm Group Labels	Other Names
Pravastatin	Drug		Pravastatin

Outcomes Module

Measure	Description	Time Frame
Incidence Rate of Stroke and TIA	Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)	up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence Rate of Atherothrombotic Infarction	Incidence rate of patients with atherothrombotic infarction	up to 5 years
Incidence Rate of Lacunar Infarction	Incidence rate of patients with lacunar infarction

Contacts/Locations Module

Name	Affiliation	Role
Masayasu Matsumoto, MD, PhD	Hiroshima University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hiroshima University		Hiroshima		734-8551	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29511130	Derived	Hosomi N, Kitagawa K, Nagai Y, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS Collaborators. Desirable Low-Density Lipoprotein Cholesterol Levels for Preventing Stroke Recurrence: A Post Hoc Analysis of the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Apr;49(4):865-871. doi: 10.1161/STROKEAHA.117.018870. Epub 2018 Mar 6.
28924103

Label	URL
Japan Statin Treatment Against Recurrent Stroke (J-STARS) only in Japanese	View source

Arm/Group Information

ID	Title	Description
FG000	Pravastatin Group	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.
FG001	Control Group	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000793 subjects FG001785 subjects
COMPLETED		FG000710 subjects FG001709 subjects
NOT COMPLETED		FG00083 subjects FG00176 subjects

Type	Comment	Reasons
Adverse Event		FG0001 subjects FG0010 subjects
Physician Decision		FG0001 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence Rate of Stroke and TIA

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

intention to treat

Posted

Number

95% Confidence Interval

events /100 person-years

up to 5 years

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pravastatin Group	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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 14.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Director of Medical Statistics Division	Translational Research Informatics Center, Kobe, Hyogo	+81-78-303-9108		kagimura@tri-kobe.org

Condition Browse Module

ID	Term
D000083242	Ischemic Stroke
D020521	Stroke
D002545	Brain Ischemia
D006937	Hypercholesterolemia
D006949	Hyperlipidemias
D012008	Recurrence

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Intervention Browse Module

ID	Term
D017035	Pravastatin

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG0020
Asian	BG000793 BG001785 BG0021578
Native Hawaiian or Other Pacific Islander	BG0000 BG0010 BG0020
Black or African American	BG0000 BG0010 BG0020
White	BG0000 BG0010 BG0020
More than one race	BG0000 BG0010 BG0020
Unknown or Not Reported	BG0000 BG0010 BG0020

Ischemic stroke subtype

Number

participants

Title

Denominators

Categories

Atherothrombotic infarction

Title	Measurements
	BG000195 BG001206 BG002401

Lacunar infarction

Title	Measurements
	BG000502 BG001504 BG0021006

Infarction of undetermined etiology

Title	Measurements
	BG00096 BG00175 BG002171

High blood pressure

The high blood pressure was defined ≥150/90 mmHg at baseline.

Number

participants

Title

Denominators

Categories

Yes

Title	Measurements
	BG000308 BG001309 BG002617

Title	Measurements
	BG000485 BG001476 BG002961

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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)	Stratified log-rank test	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus	0.8234		Hazard Ratio (HR)	0.97			2-Sided	95	0.73	1.29			the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus		Superiority or Other

Secondary

Incidence Rate of Atherothrombotic Infarction

Incidence rate of patients with atherothrombotic infarction

intention to treat

Posted

Number

95% Confidence Interval

events /100 person-years

up to 5 years

ID	Title	Description
OG000	Control Group	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
OG001	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.

Units	Counts
Participants	OG000785 OG001793

Title

Denominators

Categories

Title	Measurements
	OG0000.65(0.40 to 0.91) OG0010.21(0.06 to 0.35)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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)	Stratified log-rank test	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus	0.0047		Hazard Ratio (HR)	0.33			2-Sided	95	0.15	0.74			The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus

Secondary

Incidence Rate of Lacunar Infarction

Incidence rate of patients with lacunar infarction

intention to treat

Posted

Number

95% Confidence Interval

events /100 person years

up to 5 years

ID	Title	Description
OG000	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.
OG001	Control Group	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.

Units	Counts
Participants	OG000793 OG001785

Title

Denominators

Categories

Title	Measurements
	OG0001.26(0.90 to 1.63) OG0011.01(0.69 to 1.33)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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)	Stratified log-rank test	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus	0.3075		Hazard Ratio (HR)	1.25			2-Sided	95	0.81	1.91			The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus

Secondary

Incidence Rate of Cardioembolic Infarction

Incidence rate of patients with cardioembolic infarction

intention to treat

Posted

Number

95% Confidence Interval

events /100 person-years

up to 5 years

ID	Title	Description
OG000	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.
OG001	Control Group	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.

Units	Counts
Participants	OG000793 OG001785

Title

Denominators

Categories

Title	Measurements
	OG0000.18(0.05 to 0.32) OG0010.08(0.00 to 0.16)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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)	Stratified log-rank test	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus	0.1986		Hazard Ratio (HR)	2.36			2-Sided	95	0.61	9.14			The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus

Secondary

Incidence Rate of Intracranial Hemorrhage

Incidence rate of patients with intracranial hemorrhage

intention to treat

Posted

Number

95% Confidence Interval

events /100 person-years

up to 5 years

ID	Title	Description
OG000	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.
OG001	Control Group	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.

Units	Counts
Participants	OG000793 OG001785

Title

Denominators

Categories

Title	Measurements
	OG0000.29(0.12 to 0.46) OG0010.31(0.14 to 0.49)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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)	Stratified log-rank test	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus	0.9953		Hazard Ratio (HR)	1.00			2-Sided	95	0.45	2.22			The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus