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

Study Overview
=================
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

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

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin group<br>Rosuvastatin group | Drug: Rosuvastatin<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>Placebo group | Drug: Rosuvastatin<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days after OPCAB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statin, coronary artery bypass grafting, off-pump surgery, acute coronary syndrome