Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225849
Status:
UNKNOWN
Last Update Posted:
2005-09-26
First Post:
2005-09-22
Brief Title:
Japanese Primary Prevention Project With Aspirin
Sponsor:
Ministry of Health Labour and Welfare Japan
Organization:
Ministry of Health Labour and Welfare Japan
Study Overview
Official Title:
Japanese Primary Prevention Project With Aspirin in the Elderly With One or More Risk Factors of Vascular Events JPPP
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the balance between the risks and benefits of primary prevention by Aspirin in elderly Japanese patients with one or more cerebrocardiovascular risk factors
Detailed Description:
Cerebrocardiovascular CV death accounts for approximately 30 of total deaths in Japan and therefore it is important to establish a preventive treatment for CV events from the point of public health The guidelines proposed by a joint study group centering on the Japanese Circulation Society recommend administration of aspirin to patients with multiple risk factors for primary prevention of arteriosclerotic diseases In addition the 2002 AHA guidelines recommend use of aspirin in patients with a 10 or higher 10-year risk of CV events However these descriptions are founded on randomized comparative study results and epidemiological data obtained outside Japan while no epidemiological data are available in Japan that would allow prediction and selection of patients who could benefit from primary prevention with aspirin Although the benefit of aspirin for secondary prevention has been proven in Japanese patients the benefits of primary prevention are still controversial
JPPP is a multicenter open-label centrally randomized controlled trial In total 10000 elderly patients with one or more CV risk factors age 60-85 years combined with hypertension hyperlipidemia andor diabetes will be assigned to enteric-coated aspirin 100mgday or control The primary endpoint is composite event of CV death nonfatal stroke of any cause and nonfatal myocardial infarction
JPPP is a multicenter open-label centrally randomized controlled trial In total 10000 elderly patients with one or more CV risk factors age 60-85 years combined with hypertension hyperlipidemia andor diabetes will be assigned to enteric-coated aspirin 100mgday or control The primary endpoint is composite event of CV death nonfatal stroke of any cause and nonfatal myocardial infarction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MHLW2004-CVAdult disease-010 | None | None | None |