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This study has been withdrawn prior to enrollment.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

November 5, 2008
March 28, 2012
August 2008
May 2009   (final data collection date for primary outcome measure)
Proportion of patients whose CK-MB > 2 times above UNL [ Time Frame: First evaulation time (before PCI) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786734 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)
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

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Percutaneous Coronary Intervention
  • 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
  • Experimental: Pitavastatin Group
    Intervention: Drug: Pitavastatin
  • Usual Care Group
    Intervention: Drug: Pitavastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2010
May 2009   (final data collection date for primary outcome measure)

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)
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00786734
CWP-PTV-705
No
JW Pharmaceutical
JW Pharmaceutical
Not Provided
Principal Investigator: Ki Bae Seung, Ph.D Professor, Catholic University of Korea Kangnam St. Mary's Hospital located
JW Pharmaceutical
March 2012

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