JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

This study has been completed.

Study NCT00311402 Information provided by Boehringer Ingelheim Pharmaceuticals

Study First Received: March 28, 2006 Last Updated: February 16, 2010 History of Changes

Results First Received: February 16, 2010

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment; Primary Purpose: Prevention
Condition:	Cerebrovascular Accident
Interventions:	Drug: Aggrenox capsule Other: ASA 81 mg tablet

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient recruitment initiated from June 2006 and completed in December 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Participant Flow: Overall Study

	Aggrenox Capsule	Acetylsalicylic Acid (ASA) 81 mg Tablet
STARTED	655	639
COMPLETED	445	462
NOT COMPLETED	210	177
Adverse Event	118	105
Lost to Follow-up	0	3
Withdrawal by Subject	17	18
Lack of Efficacy	58	42
Protocol Violation	7	6
IRB's rejection etc.	10	3

Baseline Characteristics

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Reporting Groups

	Description
Aggrenox Capsule	Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
Acetylsalicylic Acid (ASA) 81 mg Tablet	ASA 81 mg, 1 tablet once daily

Baseline Measures

	Aggrenox Capsule	Acetylsalicylic Acid (ASA) 81 mg Tablet	Total
Number of Participants [units: participants]	655	639	1294
Age [units: years] Mean ± Standard Deviation	66.2 ± 8.1	66.0 ± 8.6	66.1 ± 8.4
Gender [units: participants]
Female	183	186	369
Male	472	453	925

Outcome Measures

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1. Primary:

Recurent Cerebral Infarction (Fatal or Non-fatal) [ Time Frame: maximum 124 weeks ]

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2. Secondary:

Brain (Cerebral) Haemorrhage [ Time Frame: maximum 124 weeks ]

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3. Secondary:

Subarachnoid Haemorrhage [ Time Frame: maximum 124 weeks ]

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4. Secondary:

Transient Ischemic Attack (TIA) [ Time Frame: maximum 124 weeks ]

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5. Secondary:

Acute Coronary Syndromes (ACS) [ Time Frame: maximum 124 weeks ]

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6. Secondary:

Other Vascular Events [ Time Frame: maximum 124 weeks ]

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7. Secondary:

Ischemic Vascular Event Composite Endpoint [ Time Frame: maximum 124 weeks ]

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8. Post-Hoc:

Stroke [ Time Frame: maximum 124 weeks ]

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9. Post-Hoc:

Intracranial Haemorrhage [ Time Frame: maximum 124 weeks ]

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10. Post-Hoc:

Composite Endpoint of Stroke or Major Bleeding [ Time Frame: maximum 124 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract

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
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Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

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Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	9.178
Study First Received:	March 28, 2006
Results First Received:	February 16, 2010
Last Updated:	February 16, 2010
ClinicalTrials.gov Identifier:	NCT00311402 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare