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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

JW Pharmaceutical

ClinicalTrials.gov Identifier:

NCT00786734

First received: November 5, 2008

Last updated: March 28, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 5, 2008

Last Updated Date

March 28, 2012

Start Date ^ICMJE

August 2008

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of patients whose CK-MB > 2 times above UNL [ Time Frame: First evaulation time (before PCI) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00786734 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL [ Time Frame: First evaluation time ] [ Designated as safety issue: No ]
Mean peak values of CK-MB, troponin I and myoglobin after intervention [ Time Frame: After PCI (<24hrs) ] [ Designated as safety issue: No ]
Change of hs-CRP, wall motion score [ Time Frame: Second evaluation time ] [ Designated as safety issue: No ]
Occurence of all major adverse cardiac events [ Time Frame: Second evaluation time ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Percutaneous Coronary Intervention

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Pitavastatin Group
Intervention: Drug: Pitavastatin
Usual Care Group
Intervention: Drug: Pitavastatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

July 2010

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

45 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00786734

Other Study ID Numbers ^ICMJE

CWP-PTV-705

Has Data Monitoring Committee

Responsible Party

JW Pharmaceutical

Study Sponsor ^ICMJE

JW Pharmaceutical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ki Bae Seung, Ph.D

Professor, Catholic University of Korea Kangnam St. Mary's Hospital located

Information Provided By

JW Pharmaceutical

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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