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
  Purpose

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

Condition Intervention Phase
A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Enrollment: 234
Study Start Date: October 2007
Study Completion Date: March 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin group
Rosuvastatin group
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.

Placebo Comparator: Placebo group
Placebo group
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.


  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01971606

Locations
Korea, Republic of
Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications:
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01971606     History of Changes
Other Study ID Numbers: 4-2007-0253
Study First Received: October 23, 2013
Last Updated: October 31, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
Statin, coronary artery bypass grafting, off-pump surgery, acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014