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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Percutaneous Coronary Intervention
Drug: Pitavastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by JW Pharmaceutical:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: August 2008
Study Completion Date: July 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitavastatin Group Drug: Pitavastatin
4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI
Usual Care Group Drug: Pitavastatin
4mg daily for 28 days after PCI

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786734

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00786734     History of Changes
Other Study ID Numbers: CWP-PTV-705
Study First Received: November 5, 2008
Last Updated: March 28, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by JW Pharmaceutical:
pitavastatin
PCI
stable angina

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014