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

Completed

Conditions: on-cardiac surgery, perioperative cardiac complications
Non-cardiac surgery
Surgery

Registration Number: ISRCTN47637497

Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6000

Inclusion Criteria

1. Aged 40 years or older
2. Scheduled for elective non-cardiac surgery
3. Have an estimated risk for cardiovascular death of more than 1%

Exclusion Criteria

1. The use of beta-blockers
2. A contraindication for beta-blocker use
3. The use of statins prior to randomisation
4. A contraindication for statin use
5. Unstable coronary heart disease, evidence of three-vessel disease or left main disease
6. Elevated cholesterol according to the national cholesterol consensus
7. Emergency surgery
8. Inability or unwillingness to provide written informed consent
9. 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 Myocardial Infarction (MI), in moderate and high risk patients undergoing non-cardiac surgery.

Secondary Outcome Measures

Name	Time	Method
1. To determine the impact of perioperative administration of bisoprolol and/or fluvastatin on:<br>1.1. the incidence of total mortality, cardiovascular death, and non-fatal myocardial infarction during one year follow-up<br>1.2. the length of hospital stay, and length of Intensive Care Unit (ICU)/Critical Care Unit (CCU) stay <br>1.3. the 30-day incidence of clinically significant cardiac arrhythmias and heart failure and the need for coronary revascularisation procedures<br>2. The DECREASE-IV trial has five safety objectives, namely to determine the impact of the different treatments on: <br>2.1. the 30-day congestive heart failure<br>2.2. the 30-day incidence of clinically significant bradycardia<br>2.3. the 30-day incidence of clinically significant hypotension<br>2.4. the 30-day incidence of clinically significant liver dysfunction<br>2.5. the occurence of myopathy