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

NCT00786734 | Withdrawn Phase 4

• 1 other identifier: CWP-PTV-705
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Percutaneous Coronary Intervention

Keywords

pitavastatin; PCI; stable angina

Outcome Measures

Primary Outcomes (1)

• Proportion of patients whose CK-MB > 2 times above UNL

  First evaulation time (before PCI)

Secondary Outcomes (4)

• 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

Study Arms (2)

Pitavastatin Group

EXPERIMENTAL

Drug: Pitavastatin

Usual Care Group

OTHER

Drug: Pitavastatin

Interventions

Pitavastatin DRUG

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

Pitavastatin Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with LDL ≥ 100mg/dL
• Patients who are scheduled an elective PCI for stable angina

You may not qualify if:

• 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)

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

Catholic University of Korea Kangnam St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ki Bae Seung, Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2010
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

KR (1)