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

Last updated: March 28, 2012
Sponsor: JW Pharmaceutical
Overall Status: Trial Not Available

Phase

4

Condition

Circulation Disorders

Coronary Artery Disease

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00786734
CWP-PTV-705
  • Ages 45-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with LDL ≥ 100mg/dL

  • Patients who are scheduled an elective PCI for stable angina

Exclusion

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 Start date:
August 01, 2008
Estimated Completion Date:
July 31, 2010

Study 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.

Connect with a study center

  • Catholic University of Korea Kangnam St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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