Trial · NCT00311402
JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
NCT00311402, Phase 3, Completed, Boehringer Ingelheim; results first posted 2010-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme. Trials, record NCT00311402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00311402
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme
- NCT number
- NCT00311402
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,295 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Cerebrovascular Accident
- Interventions
- Aggrenox capsule, Acetylsalicylic Acid (ASA)
- First posted
- 2006-04-06
- Last updated
- 2014-02-14
- Results first posted
- 2010-03-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) | Up to 124 weeks | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Secondary | Number of Patients With Brain (Cerebral) Haemorrhage | Up to 124 weeks | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Secondary | Number of Patients With Subarachnoid Haemorrhage | Up to 124 weeks | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Secondary | Number of Patients With Transient Ischemic Attack (TIA) | Up to 124 weeks | All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Secondary | Number of Patients With Acute Coronary Syndrome (ACS) | Up to 124 weeks | ACS contains acute myocardial infarction (MI), unstable angina and sudden cardiac death. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Secondary | Number of Patients With Other Vascular Events | Up to 124 weeks | This endpoints were defined as pulmonary embolism, retinal vascular disorder, deep vein thrombosis, peripheral artery obstruction and vascular intervention. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
| Secondary | Number of Patients With Ischemic Vascular Event Composite Endpoint | Up to 124 weeks | This is a composite endpoint of cerebral infarction, transient ischemic attack (TIA), acute myocardial infarction (MI), unstable angina and sudden death attributable to thromboembolism. All events reported by investigators were adjudicated by the independent event assessment committee in a blinded manner. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| SECONDARY | Number of Patients With Brain (Cerebral) Haemorrhage | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| SECONDARY | Number of Patients With Subarachnoid Haemorrhage | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| SECONDARY | Number of Patients With Transient Ischemic Attack (TIA) | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| SECONDARY | Number of Patients With Acute Coronary Syndrome (ACS) | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| SECONDARY | Number of Patients With Other Vascular Events | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| SECONDARY | Number of Patients With Ischemic Vascular Event Composite Endpoint | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| POST_HOC | Number of Patients With Stroke | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| POST_HOC | Number of Patients With Intracranial Haemorrhage | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
| POST_HOC | Number of Patients With Composite Endpoint of Stroke or Major Bleeding | Up to 124 weeks | All outcomes and efficacy endpoints were analysed on the basis of the full analysis set (FAS). FAS population excluded that 1) patients who did not meet inclusion criteria, 2) patients who had never taken the investigational products, and 3) patients who had no data after drug administration. | patients | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) | Aggrenox Capsule | 45 | patients | ||
| Number of Patients With First Recurrent Cerebral Infarction (Fatal or Non-fatal) | Acetylsalicylic Acid (ASA) 81 mg Tablet | 32 | patients | ||
| Number of Patients With Brain (Cerebral) Haemorrhage | Aggrenox Capsule | 12 | patients | ||
| Number of Patients With Brain (Cerebral) Haemorrhage | Acetylsalicylic Acid (ASA) 81 mg Tablet | 7 | patients | ||
| Number of Patients With Subarachnoid Haemorrhage | Aggrenox Capsule | 0 | patients | ||
| Number of Patients With Subarachnoid Haemorrhage | Acetylsalicylic Acid (ASA) 81 mg Tablet | 1 | patients | ||
| Number of Patients With Transient Ischemic Attack (TIA) | Aggrenox Capsule | 3 | patients | ||
| Number of Patients With Transient Ischemic Attack (TIA) | Acetylsalicylic Acid (ASA) 81 mg Tablet | 3 | patients | ||
| Number of Patients With Acute Coronary Syndrome (ACS) | Aggrenox Capsule | 9 | patients | ||
| Number of Patients With Acute Coronary Syndrome (ACS) | Acetylsalicylic Acid (ASA) 81 mg Tablet | 16 | patients |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aggrenox Capsule | 655 | |
| Overall Study | STARTED | Acetylsalicylic Acid (ASA) 81 mg Tablet | 639 | |
| Overall Study | COMPLETED | Aggrenox Capsule | 445 | |
| Overall Study | COMPLETED | Acetylsalicylic Acid (ASA) 81 mg Tablet | 462 | |
| Overall Study | NOT COMPLETED | Aggrenox Capsule | 210 | |
| Overall Study | NOT COMPLETED | Acetylsalicylic Acid (ASA) 81 mg Tablet | 177 |
Source ClinicalTrials.gov
Adverse events406
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 |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Aggrenox Capsule | 281 | 655 | |
| other | Nasopharyngitis | Infections and infestations | Acetylsalicylic Acid (ASA) 81 mg Tablet | 261 | 639 | |
| other | Headache | Nervous system disorders | Aggrenox Capsule | 293 | 655 | |
| other | Headache | Nervous system disorders | Acetylsalicylic Acid (ASA) 81 mg Tablet | 187 | 639 | |
| other | Dizziness | Nervous system disorders | Aggrenox Capsule | 58 | 655 | |
| other | Dizziness | Nervous system disorders | Acetylsalicylic Acid (ASA) 81 mg Tablet | 55 | 639 | |
| other | Hypertension | Vascular disorders | Aggrenox Capsule | 37 | 655 | |
| other | Hypertension | Vascular disorders | Acetylsalicylic Acid (ASA) 81 mg Tablet | 53 | 639 | |
| other | Diarrhoea | Gastrointestinal disorders | Aggrenox Capsule | 78 | 655 | |
| other | Diarrhoea | Gastrointestinal disorders | Acetylsalicylic Acid (ASA) 81 mg Tablet | 42 | 639 |
1 to 10 of 406Source ClinicalTrials.gov
See all 406 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aggrenox Capsule | ||
| Total, all-cause mortality | Acetylsalicylic Acid (ASA) 81 mg Tablet | ||
| Total, other adverse events | Aggrenox Capsule | 634 | 655 |
| Total, other adverse events | Acetylsalicylic Acid (ASA) 81 mg Tablet | 604 | 639 |
| Total, serious adverse events | Aggrenox Capsule | 178 | 655 |
| Total, serious adverse events | Acetylsalicylic Acid (ASA) 81 mg Tablet | 167 | 639 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21502757 | DERIVED |
Source PubMed
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 |
|---|
| Aggrenox Capsule vs Acetylsalicylic Acid (ASA) 81 mg Tablet: 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/NCT00311402
GET https://conductscience.org/api/trials/v1/NCT00311402/events?page=2