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

NCT ID: NCT00786734

Last Updated: 2012-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-07-31

Brief Summary

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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

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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.

Conditions

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Percutaneous Coronary Intervention

Keywords

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pitavastatin PCI stable angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pitavastatin Group

Group Type EXPERIMENTAL

Pitavastatin

Intervention Type DRUG

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

Usual Care Group

Group Type OTHER

Pitavastatin

Intervention Type DRUG

4mg daily for 28 days after PCI

Interventions

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Pitavastatin

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

Intervention Type DRUG

Pitavastatin

4mg daily for 28 days after PCI

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ki Bae Seung, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Catholic University of Korea Kangnam St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CWP-PTV-705

Identifier Type: -

Identifier Source: org_study_id