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
NCT ID: NCT01971606
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
234 participants
INTERVENTIONAL
2007-10-31
2013-03-31
Brief Summary
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-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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Rosuvastatin group
Rosuvastatin group
Rosuvastatin
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.
Placebo group
Placebo group
Rosuvastatin
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.
Interventions
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Rosuvastatin
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.
Eligibility Criteria
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Inclusion Criteria
* Age of 19 years or older
* A need for isolated surgical myocardial revascularization
* Patients with signed informed consent
Exclusion Criteria
* 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
19 Years
90 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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4-2007-0253
Identifier Type: -
Identifier Source: org_study_id