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 4

Completed

• Conditions: A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT01971606
• Lead Sponsor: Yonsei University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2012-06
• Study Completion: 2013-03
• Status Verified: 2013-10
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-10-29
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin group	Rosuvastatin	Rosuvastatin group
Placebo group	Rosuvastatin	Placebo group

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events (MACEs)	30 days after OPCAB	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.

Secondary Outcome Measures

Name	Time	Method
The degree of myocardial ischemia and inflammatory	immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB	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.

Trial Locations

Locations (1)

Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of