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NCT Number: NCT01971606

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

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

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Key information

Conditions

A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB. Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiovascular Surgery, Severance Cardiovascular Hospital , Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

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.

Primary outcomes

  1. Major adverse cardiac events (MACEs)

    Time frame: 30 days after OPCAB

    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 outcomes

  1. The degree of myocardial ischemia and inflammatory

    Time frame: immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB

    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 outcomes

  1. Incidence of postoperative atrial arrhythmia including atrial fibrillation and atrial flutter

    Time frame: 30 days after OPCAB

  2. Incidence of postoperative renal impairment or a need for dialysis

    Time frame: 30 days after OPCAB

  3. Late MACEs 2 years after OPCAB

    Time frame: 2 years after OPCAB

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Oct 29, 2013
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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