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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014