Back to resultsPitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)
Primary Purpose
Percutaneous Coronary Intervention
Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pitavastatin
Pitavastatin
Sponsored by
About this trial
This is an interventional prevention trial for Percutaneous Coronary Intervention focused on measuring pitavastatin, PCI, stable angina
Eligibility 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)
Sites / Locations
- Catholic University of Korea Kangnam St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Pitavastatin Group
Usual Care Group
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients whose CK-MB > 2 times above UNL
Secondary Outcome Measures
Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL
Mean peak values of CK-MB, troponin I and myoglobin after intervention
Change of hs-CRP, wall motion score
Occurence of all major adverse cardiac events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00786734
Brief Title
Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Coronary Intervention
Keywords
pitavastatin, PCI, stable angina
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pitavastatin Group
Arm Type
Experimental
Arm Title
Usual Care Group
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
4mg daily for 5-7 days before Percutaneous Coronary Intervention(PCI) and 4mg daily for 28 days after PCI
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
4mg daily for 28 days after PCI
Primary Outcome Measure Information:
Title
Proportion of patients whose CK-MB > 2 times above UNL
Time Frame
First evaulation time (before PCI)
Secondary Outcome Measure Information:
Title
Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL
Time Frame
First evaluation time
Title
Mean peak values of CK-MB, troponin I and myoglobin after intervention
Time Frame
After PCI (<24hrs)
Title
Change of hs-CRP, wall motion score
Time Frame
Second evaluation time
Title
Occurence of all major adverse cardiac events
Time Frame
Second evaluation time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Bae Seung, Ph.D
Organizational Affiliation
Professor, Catholic University of Korea Kangnam St. Mary's Hospital located
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Korea Kangnam St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)
We'll reach out to this number within 24 hrs