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

Phase 4

Withdrawn

• Conditions: Percutaneous Coronary Intervention
• Interventions: Drug: Pitavastatin

• Registration Number: NCT00786734
• Lead Sponsor: JW Pharmaceutical

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Primary Completion: 2009-05
• Study Completion: 2010-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-28
• Last Update Posted: 2012-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin Group	Pitavastatin	-
Usual Care Group	Pitavastatin	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients whose CK-MB > 2 times above UNL	First evaulation time (before PCI)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Catholic University of Korea Kangnam St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of