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

Percutaneous Coronary Intervention Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00786734
• Other study ID #: CWP-PTV-705
• Status: Withdrawn
• Phase: Phase 4
• First received: November 5, 2008
• Last updated: March 28, 2012
• Start date: August 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2012
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 ?b/?a receptor inhibitor (<4 weeks)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Percutaneous Coronary Intervention

Intervention

Drug:
• Pitavastatin
4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI
• Pitavastatin
4mg daily for 28 days after PCI

Locations

Country	Name	City	State
Korea, Republic of	Catholic University of Korea Kangnam St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients whose CK-MB > 2 times above UNL		First evaulation time (before PCI)	No
Secondary	Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL		First evaluation time	No
Secondary	Mean peak values of CK-MB, troponin I and myoglobin after intervention		After PCI (<24hrs)	No
Secondary	Change of hs-CRP, wall motion score		Second evaluation time	No
Secondary	Occurence of all major adverse cardiac events		Second evaluation time	No