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WithdrawnNCT00786734Updated Mar 30, 2012

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

A Phase 4 interventional study of Pitavastatin and Pitavastatin in Percutaneous Coronary Intervention, sponsored by JW Pharmaceutical. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-03-30.

Sponsored by JW Pharmaceutical · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
45 Years to 75 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Percutaneous Coronary Intervention

Keywords

  • pitavastatin
  • PCI
  • stable angina
03

In context

Angina Pectoris

519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.

Browse Angina Pectoris studies →

Lead sponsor

JW Pharmaceutical is the lead sponsor of 75 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Pitavastatin Group

    Drug: Pitavastatin

  • Other
    Usual Care Group

    Drug: Pitavastatin

Interventions

  • DrugPitavastatin

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

  • DrugPitavastatin

    4mg daily for 28 days after PCI

06

What researchers measure

Primary outcomes

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

    Time frame: First evaulation time (before PCI)

Secondary outcomes

  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

07

Study locations

1 site
  • Catholic University of Korea Kangnam St. Mary's Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00786734
Lead sponsor
JW Pharmaceutical
Responsible party
Sponsor
First posted
Nov 6, 2008
Start date
Aug 2008
Primary completion
May 2009
Completion
Jul 2010
Last update
Mar 30, 2012

Study contacts

Ki Bae Seung, Ph.D
principal investigator · Professor, Catholic University of Korea Kangnam St. Mary's Hospital located

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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