ClinicalTrials.gov
ClinicalTrials.gov Menu

Japan Statin Treatment Against Recurrent Stroke (J-STARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00221104
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : January 25, 2018
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Ministry of Health, Labour and Welfare, Japan
Hiroshima University
Information provided by (Responsible Party):
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Ischemic Stroke
Intervention: Drug: Pravastatin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from March 2004 and February 2009 recruited at 123 clinical sites in Japan

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
Control Group The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.

Participant Flow:   Overall Study
    Pravastatin Group   Control Group
STARTED   793   785 
COMPLETED   710   709 
NOT COMPLETED   83   76 
Adverse Event                1                0 
Physician Decision                1                0 
Protocol Violation                2                0 
Withdrawal by Subject                42                29 
Others                37                47 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
intention to treat

Reporting Groups
  Description
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.
Control Group The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
Total Total of all reporting groups

Baseline Measures
   Pravastatin   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 793   785   1578 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      335  42.2%      329  41.9%      664  42.1% 
>=65 years      458  57.8%      456  58.1%      914  57.9% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      248  31.3%      243  31.0%      491  31.1% 
Male      545  68.7%      542  69.0%      1087  68.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      793 100.0%      785 100.0%      1578 100.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      0   0.0%      0   0.0%      0   0.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Japan   793   785   1578 
Ischemic stroke subtype 
[Units: Participants]
     
Atherothrombotic infarction   195   206   401 
Lacunar infarction   502   504   1006 
Infarction of undetermined etiology   96   75   171 
High blood pressure [1] 
[Units: Participants]
     
Yes   308   309   617 
No   485   476   961 
[1] The high blood pressure was defined ≥150/90 mmHg at baseline.
Diabetes mellitus 
[Units: Participants]
     
Yes   185   184   369 
No   608   601   1209 


  Outcome Measures

1.  Primary:   Incidence Rate of Stroke and TIA   [ Time Frame: up to 5 years ]

2.  Secondary:   Incidence Rate of Atherothrombotic Infarction   [ Time Frame: up to 5 years ]

3.  Secondary:   Incidence Rate of Lacunar Infarction   [ Time Frame: up to 5 years ]

4.  Secondary:   Incidence Rate of Cardioembolic Infarction   [ Time Frame: up to 5 years ]

5.  Secondary:   Incidence Rate of Intracranial Hemorrhage   [ Time Frame: up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director of Medical Statistics Division
Organization: Translational Research Informatics Center, Kobe, Hyogo
phone: +81-78-303-9108
e-mail: kagimura@tri-kobe.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00221104     History of Changes
Other Study ID Numbers: J-STARS
C000000207 ( Other Identifier: UMIN CTR )
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: July 6, 2016
Results First Posted: January 25, 2018
Last Update Posted: January 25, 2018