Fluvastatin and bisoprolol for the reduction of perioperative cardiac mortality and morbidity in high-risk patients undergoing non-cardiac surgery.

Recruiting

Conditions: non-cardiac surgery
beta-blocker
statin
perioperative cardiac complications

Registration Number: NL-OMON21523

Lead Sponsor: Department of Anesthesiology, Erasmus MC Rotterdam, the Netherlands

Brief Summary: Fluvastatin and bisoprolol for the reduction of perioperative cardiac mortality and morbidity in high-risk patients undergoing non-cardiac surgery: rationale and design of the DECREASE-IV study. Am Heart J. 2004 Dec;148(6):1047-52.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 6000

Inclusion Criteria

Patients who are (1) aged 40 years or older, (2) scheduled for elective noncardiac surgery and (3) have an estimated risk for cardiovascular death of more than 1%, will be enrolled in the DECREASE-IV trial.

Exclusion Criteria

Exclusion criteria for this trial are: the use of beta-blockers; a contraindication for beta-blocker use; the use of statins prior to randomisation; a contraindication for statin use; unstable coronary heart disease, evidence of 3-vessel disease or left main disease; elevated cholesterol according to the national cholesterol consensus; emergency surgery; unability or unwillingness to provide written informed consent; and previous participation in this same trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy objective is to determine the impact of perioperative administration of bisoprolol, fluvastatin and their combination on the incidence of 30-day cardiovascular events, i.e. the composite of cardiac death, and non fatal MI, in moderate and high risk patients undergoing noncardiac surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy objectives of the DECREASE-IV study are <br>1. To determine the impact of perioperative administration of bisoprolol and/or fluvastatin on:<br>a.The incidence of total mortality, cardiovascular death, and nonfatal myocardial infarction during 1 year follow-up; <br>b. The length of hospital stay, and length of ICU/CCU stay; <br>c. The 30-day incidence of clinically significant cardiac arrhythmias and heartfailure and the need for coronary revascularisation procedures. <br>2. The DECREASE-IV trial has five safety objectives, namely:<br>a. To determine the impact of the different treatments on: (1) the 30-day congestive heart failure; <br>b. The 30-day incidence of clinically significant bradycardia; <br>c. The 30-day incidence of clinically significant hypotension; <br>d. The 30-day incidence of clinically significant liver dysfunction;<br>e. The occurence of myopathy.