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).
Primary Outcome Measures:
- Proportion of patients whose CK-MB > 2 times above UNL [ Time Frame: First evaulation time (before PCI) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL [ Time Frame: First evaluation time ] [ Designated as safety issue: No ]
- Mean peak values of CK-MB, troponin I and myoglobin after intervention [ Time Frame: After PCI (<24hrs) ] [ Designated as safety issue: No ]
- Change of hs-CRP, wall motion score [ Time Frame: Second evaluation time ] [ Designated as safety issue: No ]
- Occurence of all major adverse cardiac events [ Time Frame: Second evaluation time ] [ Designated as safety issue: No ]
| 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) |
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Pitavastatin Group: Experimental
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Drug: Pitavastatin
4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI
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Usual Care Group
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Drug: Pitavastatin
4mg daily for 28 days after PCI
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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.
Purpose
