A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB. Clinical Trial
| Verified date | October 2013 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 234 |
| Est. completion date | March 2013 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Incidence of postoperative atrial arrhythmia including atrial fibrillation and atrial flutter | 30 days after OPCAB | No | |
| Other | Incidence of postoperative renal impairment or a need for dialysis | 30 days after OPCAB | No | |
| Other | Late MACEs 2 years after OPCAB | 2 years after OPCAB | No | |
| Primary | 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 | No |
| Secondary | 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 | No |