Trial · NCT00221104
Japan Statin Treatment Against Recurrent Stroke (J-STARS)
NCT00221104, Phase 3, Completed, Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; results first posted 2018-01-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Japan Statin Treatment Against Recurrent Stroke (J-STARS). Trials, record NCT00221104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00221104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Japan Statin Treatment Against Recurrent Stroke (J-STARS)
- NCT number
- NCT00221104
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,578 participants, actual
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Conditions
- Ischemic Stroke
- Interventions
- Pravastatin
- First posted
- 2005-09-22
- Last updated
- 2018-01-25
- Results first posted
- 2018-01-25
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Stroke and TIA | up to 5 years | Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA) |
| Secondary | Incidence Rate of Atherothrombotic Infarction | up to 5 years | Incidence rate of patients with atherothrombotic infarction |
| Secondary | Incidence Rate of Lacunar Infarction | up to 5 years | Incidence rate of patients with lacunar infarction |
| Secondary | Incidence Rate of Cardioembolic Infarction | up to 5 years | Incidence rate of patients with cardioembolic infarction |
| Secondary | Incidence Rate of Intracranial Hemorrhage | up to 5 years | Incidence rate of patients with intracranial hemorrhage |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Stroke and TIA | up to 5 years | intention to treat | events /100 person-years | NUMBER |
| SECONDARY | Incidence Rate of Atherothrombotic Infarction | up to 5 years | intention to treat | events /100 person-years | NUMBER |
| SECONDARY | Incidence Rate of Lacunar Infarction | up to 5 years | intention to treat | events /100 person years | NUMBER |
| SECONDARY | Incidence Rate of Cardioembolic Infarction | up to 5 years | intention to treat | events /100 person-years | NUMBER |
| SECONDARY | Incidence Rate of Intracranial Hemorrhage | up to 5 years | intention to treat | events /100 person-years | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Stroke and TIA | Pravastatin | 2.56 | 95% Confidence Interval 2.04 to 3.08 | events /100 person-years | |
| Incidence Rate of Stroke and TIA | Control Group | 2.65 | 95% Confidence Interval 2.12 to 3.18 | events /100 person-years | |
| Incidence Rate of Atherothrombotic Infarction | Control Group | 0.65 | 95% Confidence Interval 0.40 to 0.91 | events /100 person-years | |
| Incidence Rate of Atherothrombotic Infarction | Pravastatin | 0.21 | 95% Confidence Interval 0.06 to 0.35 | events /100 person-years | |
| Incidence Rate of Lacunar Infarction | Pravastatin | 1.26 | 95% Confidence Interval 0.90 to 1.63 | events /100 person years | |
| Incidence Rate of Lacunar Infarction | Control Group | 1.01 | 95% Confidence Interval 0.69 to 1.33 | events /100 person years | |
| Incidence Rate of Cardioembolic Infarction | Pravastatin | 0.18 | 95% Confidence Interval 0.05 to 0.32 | events /100 person-years | |
| Incidence Rate of Cardioembolic Infarction | Control Group | 0.08 | 95% Confidence Interval 0.00 to 0.16 | events /100 person-years | |
| Incidence Rate of Intracranial Hemorrhage | Pravastatin | 0.29 | 95% Confidence Interval 0.12 to 0.46 | events /100 person-years | |
| Incidence Rate of Intracranial Hemorrhage | Control Group | 0.31 | 95% Confidence Interval 0.14 to 0.49 | events /100 person-years |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pravastatin Group | 793 | |
| Overall Study | STARTED | Control Group | 785 | |
| Overall Study | COMPLETED | Pravastatin Group | 710 | |
| Overall Study | COMPLETED | Control Group | 709 | |
| Overall Study | NOT COMPLETED | Pravastatin Group | 83 | |
| Overall Study | NOT COMPLETED | Control Group | 76 |
Source ClinicalTrials.gov
Adverse events520
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Anaemia | Blood and lymphatic system disorders | Pravastatin Group | 1 | 780 | |
| serious | Anaemia | Blood and lymphatic system disorders | Control Group | 2 | 785 | |
| serious | Angina pectoris | Cardiac disorders | Pravastatin Group | 3 | 780 | |
| serious | Angina pectoris | Cardiac disorders | Control Group | 3 | 785 | |
| serious | Angina unstable | Cardiac disorders | Pravastatin Group | 2 | 780 | |
| serious | Angina unstable | Cardiac disorders | Control Group | 6 | 785 | |
| serious | Aortic valve incompetence | Cardiac disorders | Pravastatin Group | 1 | 780 | |
| serious | Aortic valve incompetence | Cardiac disorders | Control Group | 0 | 785 | |
| serious | Arrhythmia | Cardiac disorders | Pravastatin Group | 2 | 780 | |
| serious | Arrhythmia | Cardiac disorders | Control Group | 0 | 785 |
1 to 10 of 520Source ClinicalTrials.gov
See all 520 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pravastatin Group | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Pravastatin Group | 0 | 0 |
| Total, other adverse events | Control Group | 0 | 0 |
| Total, serious adverse events | Pravastatin Group | 188 | 780 |
| Total, serious adverse events | Control Group | 164 | 785 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pravastatin Group vs Control Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00221104
GET https://conductscience.org/api/trials/v1/NCT00221104/events?page=2