UMIN ID: UMIN000002351
Registered date:01/06/2010
Effect of Cilostazol compared with Clopidogrel about prevention of myocardial injury after elective percutaneous coronary intervention :Prospective,Randomized,Open,Blinded-Endpoint trial
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | ischemic heart disease |
| Date of first enrollment | 2009/09/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Patients will be given Aspirin 100mg + cilostazol 200mg orally twice daily. Both drugs will be administered to patients starting seven days or more prior to PCI. Patients will be given Aspirin 100mg orally once daily + clopidogrel 75mg orally once daily. Both drugs will be administered to patients starting seven days or more prior to PCI. |
Outcome(s)
| Primary Outcome | 1.Frequency of increase of troponin-I above the upper limit of normal 2.Frequency of increase of CK >2 times above the upper limit of normal 3.Frequency of increase of CK-MB>2 times above the upper limit of normal 4.Average value of cardiac enzymes (CK/CK-MB/troponin-I) 5.Average rate of change of cardiac enzymes (CK/CK-MB/troponin-I) |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)Patients with unstable angina (2)Patients who use drug-eluting stents (DES) (3)Patients with a medical history of acute myocardial infarction within three months (4)Patients whose levels of CK and CK-MB,troponin-I are above upper limits of normal at the time of consent acquisition (5)Patients taking an anticoagulant (warfarin) (6)Patients who have a medical history of hypersensitivity to cilostazol, aspirin, and/or clopidogrel (7)Patients with thrombocytopenia (8)Patients with hepatic dysfunction (AST (GOT) or ALT(GPT) > 100 IU/L within three months) (9)Patients with renal dysfunction (serum creatinine >2.0mg/dl within three months) (10)Patients with congestive heart failure (11)Patients who are pregnant (12)Patients with bleeding |
Related Information
| Primary Sponsor | Department of Cardiology, Nagoya University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Cardiology, Nagoya University Graduate School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hideki Ishii |
| Address | Japan |
| Telephone | |
| Affiliation | Nagoya University Graduate School of Medicine Department of Cardiology |
| scientific contact | |
| Name | Toyoaki Murohara |
| Address | 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan Japan |
| Telephone | |
| Affiliation | Nagoya University Graduate School of Medicine Department of Cardiology |