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

March 28, 2012 updated by: JW Pharmaceutical

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL
Time Frame: First evaluation time
First evaluation time
Mean peak values of CK-MB, troponin I and myoglobin after intervention
Time Frame: After PCI (<24hrs)
After PCI (<24hrs)
Change of hs-CRP, wall motion score
Time Frame: Second evaluation time
Second evaluation time
Occurence of all major adverse cardiac events
Time Frame: Second evaluation time
Second evaluation time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Ki Bae Seung, Ph.D, Professor, Catholic University of Korea Kangnam St. Mary's Hospital located

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 5, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 30, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWP-PTV-705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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