Clinical 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.
Keywords: Statin, coronary artery bypass grafting, off-pump surgery, acute coronary syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 234
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Major adverse cardiac events (MACEs)
timeFrame: 30 days after OPCAB
Secondary outcomes:
measure: The degree of myocardial ischemia and inflammatory
timeFrame: immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB
Other outcomes:
measure: Incidence of postoperative atrial arrhythmia including atrial fibrillation and atrial flutter
timeFrame: 30 days after OPCAB
measure: Incidence of postoperative renal impairment or a need for dialysis
timeFrame: 30 days after OPCAB
measure: Late MACEs 2 years after OPCAB
timeFrame: 2 years after OPCAB
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Study officials:
References:
citation: Patti G, Pasceri V, Colonna G, Miglionico M, Fischetti D, Sardella G, Montinaro A, Di Sciascio G. Atorvastatin pretreatment improves outcomes in patients with acute coronary syndromes undergoing early percutaneous coronary intervention: results of the ARMYDA-ACS randomized trial. J Am Coll Cardiol. 2007 Mar 27;49(12):1272-8. doi: 10.1016/j.jacc.2007.02.025.