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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01971606
First received: October 23, 2013
Last updated: October 31, 2013
Last verified: October 2013

October 23, 2013
October 31, 2013
October 2007
June 2012   (final data collection date for primary outcome measure)
Major adverse cardiac events (MACEs) [ Time Frame: 30 days after OPCAB ] [ Designated as safety issue: No ]
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.
The degree of myocardial ischemia and inflammatory [ Time Frame: immediate, 24hours, 48hours, 72hours, 7days after OPCAB. ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01971606 on ClinicalTrials.gov Archive Site
The degree of myocardial ischemia and inflammatory [ Time Frame: immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB ] [ Designated as safety issue: No ]
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.
Major adverse cardiac events (MACEs) [ Time Frame: immediate, 24hours, 48hours, 72 hours, 7 days after OPCAB. ] [ Designated as safety issue: No ]
  • 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.
  • Incidence of postoperative atrial arrhythmia including atrial fibrillation and atrial flutter.
  • Incidence of postoperative renal impairment or a need for dialysis.
  • late MACEs 2 years after OPCAB
  • Incidence of postoperative atrial arrhythmia including atrial fibrillation and atrial flutter [ Time Frame: 30 days after OPCAB ] [ Designated as safety issue: No ]
  • Incidence of postoperative renal impairment or a need for dialysis [ Time Frame: 30 days after OPCAB ] [ Designated as safety issue: No ]
  • Late MACEs 2 years after OPCAB [ Time Frame: 2 years after OPCAB ] [ Designated as safety issue: No ]
Not Provided
 
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
Not Provided

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.
Drug: 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.

  • Experimental: Rosuvastatin group
    Rosuvastatin group
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Placebo group
    Placebo group
    Intervention: Drug: Rosuvastatin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
March 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
19 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01971606
4-2007-0253
Yes
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP