UMIN ID: UMIN000000888
Registered date:15/11/2007
Coronary Artery Dysfunction After Stent Implantation and Effect of Aggressive Lipid-lowering Therapy by Statins - Role of Rho-kinase -
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Ischemic heart disease |
| Date of first enrollment | 2007/11/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Control therapy: Slow-release nifedipine (Adalat CR) 20/40mg/day or slow-release diltiazem (Herbesser R) 200mg/day if hypotension is a concern. Lipid-lowering therapy to achieve LDL-Chol<100mg/dl with statins if needed. Experimental therapy: Slow-release nifedipine (Adalat CR) 20/40mg/day or slow-release diltiazem (Herbesser R) 200mg/day if hypotension is a concern. Aggressive lipid-lowering therapy to achieve LDL-Chol<70mg/dl with pitavastatin (Livalo) 2-4mg/day. |
Outcome(s)
| Primary Outcome | Coronary vasospasm after 3-month trial therapy |
|---|---|
| Secondary Outcome | 1) Cardiovascular events (cardiac death, myocardial infarction, revascularization by PCI or CABG) 2) Severity of angina by Canadian Cardiovascular Society (CCS) classification 3) Biomarkers in peripheral and coronary sinus blood 4) Coronary stenosis and plaque phenotype by angiography or intravascular ultrasound (IVUS) 5) Stent re-endothelialization by angioscopy or optical coherence tomography (OCT) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patient with unstable angina or acute myocardial infarction 2. History of angiographycally-proven vasospastic angina 3. Contraindication for statins or calcium channel blockers 4. Familial hypercholesterolemia, liver cirrhosis or renal failure on chronic dialysis 5. Contraindication for intracoronary acetylcholine during coronary angiography |
Related Information
| Primary Sponsor | Kyushu University Graduate School of Medical Sciences Department of Cardiovascular Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Kyushu University Graduate School of Medical Sciences Department of Cardiovascular Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tetsuya Matoba |
| Address | 3-1-1Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan Japan |
| Telephone | 092-642-5360 |
| matoba@cardiol.med.kyushu-u.ac.jp | |
| Affiliation | Kyushu University Graduate School of Medical Sciences Department of Cardiovascular Medicine |
| scientific contact | |
| Name | Kenji Sunagawa |
| Address | 3-1-1Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan Japan |
| Telephone | 092-642-5360 |
| Affiliation | Kyushu University Graduate School of Medical Sciences Department of Cardiovascular Medicine |