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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 9, 2005 | ||||||||
| Last Updated Date | September 22, 2008 | ||||||||
| Start Date ICMJE | December 2002 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00110448 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE |
other arteriosclerotic disease, which needs internal medicine and/or surgical medical treatment | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial | ||||||||
| Official Title ICMJE | Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial | ||||||||
| Brief Summary | The purpose of this study is to determine the effects of low-dose aspirin for the primary prevention of vascular events in patients with type 2 diabetes in Japan. |
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| Detailed Description | There is a worldwide epidemic of diabetes and the number of individuals with diabetes is set to increase further. As individuals with diabetes are at high risk of accelerated atherosclerosis and thrombotic vascular events, the significant proportion of the cardiovascular disease burden is projected to be among this population. JPAD is a multicenter study with a prospective randomized open, blinded end-point (PROBE) design. The doses administered are aspirin 81 mg/day or 100 mg/day, the latter being enteric-coated Aspirin. The primary objective was to compare the effect of aspirin on atherosclerotic events including cardiovascular events, cerebral vascular event, and other vascular events. We also analyze hemorrhagic events in this RCT. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | Ogawa H, Nakayama M, Morimoto T, Uemura S, Kanauchi M, Doi N, Jinnouchi H, Sugiyama S, Saito Y; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2008 Nov 12;300(18):2134-41. Epub 2008 Nov 9. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 2539 | ||||||||
| Completion Date | July 2008 | ||||||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 30 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Japan | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00110448 | ||||||||
| Responsible Party | Hisao Ogawa, Kumamoto University | ||||||||
| Study ID Numbers ICMJE | H14-Kouka(Seikatsu)-025 | ||||||||
| Study Sponsor ICMJE | Kumamoto University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Kumamoto University | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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