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Sponsored by: |
ChoongWae Pharma Corporation |
---|---|
Information provided by: | ChoongWae Pharma Corporation |
ClinicalTrials.gov Identifier: | NCT00786734 |
Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).
Condition | Intervention | Phase |
---|---|---|
Percutaneous Coronary Intervention |
Drug: Pitavastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open Label, Comparative Study to Evaluate Effect of Pitavastatin for Reduction of Myocardial Damage in Patient Are Scheduled Elective PCI for Stable Angina Pectoris |
Estimated Enrollment: | 150 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Pitavastatin Group: Experimental |
Drug: Pitavastatin
4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI
|
Usual Care Group |
Drug: Pitavastatin
4mg daily for 28 days after PCI
|
Procedural ischemic myocardial injury remains the most frequent complication after coronary angioplasty. Recently it was reported that pretreatment with atorvastatin reduce the myocardial damage compared to placebo. Thus, we will evaluate the difference of pretreatment of pitavastatin compared to standard therapy on the reduction of myocardial damage in patient who is scheduled elective PCI for stable angina pectoris.
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Choongwae Pharma Corporation | 82-2-840-6777 |
Korea, Republic of | |
Catholic University of Korea Kangnam St. Mary's Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Ki Bae Seung, Ph.D |
Principal Investigator: | Ki Bae Seung, Ph.D | Professor, Catholic University of Korea Kangnam St. Mary's Hospital located |
Responsible Party: | Choongwae Pharma Corporation ( Seoyoung, Kim / Clinical Research Team ) |
Study ID Numbers: | CWP-PTV-705 |
Study First Received: | November 5, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00786734 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
pitavastatin PCI stable angina |
Signs and Symptoms Heart Diseases NK 104 Myocardial Ischemia Vascular Diseases |
Angina Pectoris Pain Ischemia Chest Pain |
Signs and Symptoms Heart Diseases Molecular Mechanisms of Pharmacological Action NK 104 Myocardial Ischemia Vascular Diseases |
Angina Pectoris Enzyme Inhibitors Pain Cardiovascular Diseases Pharmacologic Actions Chest Pain |