Percutaneous Coronary Intervention
Conditions
Keywords
pitavastatin, PCI, stable angina
Brief summary
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).
Detailed description
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.
Interventions
DRUGPitavastatin
4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with LDL ≥ 100mg/dL * Patients who are scheduled an elective PCI for stable angina
Exclusion criteria
* Acute myocardial infarction (\<3 months) * Unstable angina * Previous treatment with statins (\<6 months) * Increase in CK-MB above upper normal limit * Increase in liver enzymes (AST/ALT) above 2 times of upper normal limit * Increase in serum creatinine above 2 times of upper normal limit * Left ventricular ejection fraction \<30% * Previous treatment with glycoprotein Ⅱb/Ⅲa receptor inhibitor (\<4 weeks)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients whose CK-MB > 2 times above UNL | First evaulation time (before PCI) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL | First evaluation time |
| Mean peak values of CK-MB, troponin I and myoglobin after intervention | After PCI (<24hrs) |
| Change of hs-CRP, wall motion score | Second evaluation time |
| Occurence of all major adverse cardiac events | Second evaluation time |
Countries
South Korea
Outcome results
None listed