Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)

Study Overview
=================
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.

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

Conditions
-----------------
Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Drug: Pitavastatin
* Drug: Pitavastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin Group<br> | Drug: Pitavastatin<br>* 4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI<br>|
| Other: Usual Care Group<br> | Drug: Pitavastatin<br>* 4mg daily for 28 days after PCI<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients whose CK-MB > 2 times above UNL |  | First evaulation time (before PCI) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pitavastatin, PCI, stable angina