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

JW Pharmaceutical

Status and phase: Withdrawn; Phase 4

Conditions: Percutaneous Coronary Intervention

Treatments: Drug: Pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00786734

CWP-PTV-705

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Pitavastatin Group

Experimental group

Treatment:

Drug: Pitavastatin

Drug: Pitavastatin

Usual Care Group

Other group

Treatment:

Drug: Pitavastatin

Drug: Pitavastatin