drugset / Trial / NCT00225849
Japanese Primary Prevention Project With Aspirin
Phase 4
Unknown
10000 enrolled
Ministry of Health, Labour and Welfare, Japan
Bayer · collabJapan Heart Foundation · collab
RandomizedParallel-groupOpen-labelPrevention
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 cerebro/cardiovascular risk factors
Timeline
- Start
- 2005-03
- Primary completion
- —
- Completion
- 2010-09
Outcome
Missed primary endpoint
paper The 5-year cumulative primary outcome event rate was not significantly different between the groups (2.77% [95% CI, 2.40%-3.20%] for aspirin vs 2.96% [95% CI, 2.58%-3.40%] for no aspirin; hazard ratio [HR], 0.94 [95% CI, 0.77-1.15]; P = .54). PMID 25401325 ↗
paper did not significantly reduce the risk of the composite outcome of cardiovascular death, nonfatal stroke, and nonfatal myocardial infarction PMID 25401325 ↗
Publications
- Sugawara M, Goto Y, Yamazaki T, Teramoto T, Oikawa S, Shimada K, Uchiyama S, Ando K, Ishizuka N, Murata M, Yokoyama K, Uemura Y, Ikeda Y; Japanese Primary Prevention Project (JPPP) Study Group. Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Elderly Japanese Patients with Atherosclerotic Risk Factors: Subanalysis of a Randomized Clinical Trial (JPPP-70). Am J Cardiovasc Drugs. 2019 Jun;19(3):299-311. doi: 10.1007/s40256-018-0313-0.
- Uchiyama S, Ishizuka N, Shimada K, Teramoto T, Yamazaki T, Oikawa S, Sugawara M, Ando K, Murata M, Yokoyama K, Minematsu K, Matsumoto M, Ikeda Y; JPPP Study Group. Aspirin for Stroke Prevention in Elderly Patients With Vascular Risk Factors: Japanese Primary Prevention Project. Stroke. 2016 Jun;47(6):1605-11. doi: 10.1161/STROKEAHA.115.012461. Epub 2016 May 10.
- Ikeda Y, Shimada K, Teramoto T, Uchiyama S, Yamazaki T, Oikawa S, Sugawara M, Ando K, Murata M, Yokoyama K, Ishizuka N. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2510-20. doi: 10.1001/jama.2014.15690.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 100 mg | — |