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

NCT01971606 | Completed Phase 4 DMC

• 1 other identifier: 4-2007-0253
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

A Total of 234 Patients With Acute Coronary Syndrome Who Will Undergo OPCAB.

Keywords

Statin, coronary artery bypass grafting, off-pump surgery, acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACEs)

  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.

  30 days after OPCAB

Secondary Outcomes (1)

• The degree of myocardial ischemia and inflammatory

  immediate, 24 hours, 48 hours, 72 hours, 7 days after OPCAB

Other Outcomes (3)

• Incidence of postoperative atrial arrhythmia including atrial fibrillation and atrial flutter

  30 days after OPCAB

• Incidence of postoperative renal impairment or a need for dialysis

  30 days after OPCAB

• Late MACEs 2 years after OPCAB

  2 years after OPCAB

Study Arms (2)

Rosuvastatin group

EXPERIMENTAL

Rosuvastatin group

Drug: Rosuvastatin

Placebo group

PLACEBO COMPARATOR

Placebo group

Drug: Rosuvastatin

Interventions

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.

Placebo group; Rosuvastatin group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 17394957 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2013
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

KR (1)