Impact of High-dose Pretreatment of Rosuvastatin in Patients With Acute Coronary Syndrome Following Off-pump Coronary Artery Bypass: Results From the HIROP-ACS (HIgh-dose Pretreatment of Rosuvastatin During Off-Pump Coronary Bypass in Acute Coronary

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Periprocedural treatment with high-dose statins is known to have cardioprotective and pleiotropic effects, such as anti-thrombotic and anti-inflammatory actions.

-Objective: to determine whether preoperative rosuvastatin loading is independently associated with reduced myocardial ischemia and clinical outcomes in patients with stable angina undergoing isolated off-pump coronary bypass (OPCAB) in patients with acute coronary syndrome.

Study design

• Prospective, double-blinded, single-center study of each 117 subjects enrolled

• Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled preoperatively.

• Eligible subjects will be randomized 1:1 to A) High-dose rosuvastatin (n=117) vs. B) Placebo (n=117).

• The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a total

• All subjects will undergo OPCAB procedure. - The primary and secondary endpoints will be compared at 30 days and 2 years postoperatively between two groups

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• The presence of acute coronary syndrome, including unstable angina, acute non-ST elevation myocardial infarction

• Age of 19 years or older

• A need for isolated surgical myocardial revascularization

• Patients with signed informed consent

Exclusion Criteria:

• Patients with combined surgery with coronary bypass grafting

• On-pump conversion

• Patients with any increase in liver enzymes

• Patients with history of liver or muscle disease.

• Patients with moderate renal dysfunction (creatinine>2.0mg/dl) or need for dialysis

• Re-do surgery

• Urgent/emergent surgery