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

Phase 4CompletedNCT01971606

Yonsei University234 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

234

Conditions

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

Interventions

RosuvastatinDRUG

Patients will be randomized in a ratio of 1:1 to A) High-dose rosuvastatin vs. B) Placebo. A) Rosuvastatin group : Administration of 40mg of rosuvastatin PO 12 hours before surgery and 20mg of rosuvastatin PO 2hours before surgery and 10mg of rosuvastatin PO daily at postoperative period. B) Placebo group : Administration of placebo at 12 hours and 2 hours before surgery and 10mg of rosuvastatin PO daily at postoperative period.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Major adverse cardiac events (MACEs)

Major adverse cardiac events (MACEs), which include the following: death from all causes, non-fatal myocardial infarction (MI), and repeat revascularization by percutaneous intervention or bypass surgery within 30 days after OPCAB.

Time frame: 30 days after OPCAB

Secondary Outcomes

The degree of myocardial ischemia and inflammatory

The degree of myocardial ischemia and inflammatory changes assessed by blood sampling and specific tests (CK-MB, Troponin T, ESR, CRP, hs-CRP) at the early period after OPCAB.

Time frame: immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB