drugset / Trial / NCT01971606

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

NCT01971606 ↗

Phase 4 Completed 234 enrolled Yonsei University
RandomizedParallel-groupDouble-blindSupportive care

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

Timeline

Start
2007-10
Primary completion
2012-06
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Rosuvastatin Small molecule 10 mg Oral

Indications

No indication recorded.