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

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ClinicalTrials.gov Identifier: NCT00786734
Recruitment Status : Withdrawn
First Posted : November 6, 2008
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical

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 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 Type : Interventional  (Clinical Trial)
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 : August 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Proportion of patients whose CK-MB > 2 times above UNL [ Time Frame: First evaulation time (before PCI) ]

Secondary Outcome Measures :
  1. Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL [ Time Frame: First evaluation time ]
  2. Mean peak values of CK-MB, troponin I and myoglobin after intervention [ Time Frame: After PCI (<24hrs) ]
  3. Change of hs-CRP, wall motion score [ Time Frame: Second evaluation time ]
  4. Occurence of all major adverse cardiac events [ Time Frame: Second evaluation time ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT00786734     History of Changes
Other Study ID Numbers: CWP-PTV-705
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by JW Pharmaceutical:
pitavastatin
PCI
stable angina

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