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

Sponsor

JW Pharmaceutical (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00786734

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Coronary Intervention	Drug: Pitavastatin Drug: Pitavastatin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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
Other: Usual Care Group	Drug: Pitavastatin 4mg daily for 28 days after PCI

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

Other: Usual Care Group

Drug: Pitavastatin

4mg daily for 28 days after PCI

Outcome Measures

Primary Outcome Measures

Proportion of patients whose CK-MB > 2 times above UNL [First evaulation time (before PCI)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of Korea Kangnam St. Mary's Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

JW Pharmaceutical

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JW Pharmaceutical

ClinicalTrials.gov Identifier:

NCT00786734

Other Study ID Numbers:

CWP-PTV-705

First Posted:

Nov 6, 2008

Last Update Posted:

Mar 30, 2012

Last Verified:

Mar 1, 2012

Keywords provided by JW Pharmaceutical

pitavastatin

PCI

stable angina

Additional relevant MeSH terms:

Angina Pectoris

Angina, Stable

Pitavastatin

Study Results

No Results Posted as of Mar 30, 2012