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 Syndrome) Study

Yonsei University

Status and phase

Completed

Phase 4

Conditions

A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.

Treatments

Drug: Rosuvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01971606

4-2007-0253

Details and patient eligibility

About

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

Enrollment

234 patients

Sex

All

Ages

19 to 90 years old

Volunteers

No Healthy Volunteers

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