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

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR900
• Date of registration: 12/02/2007
• Primary sponsor: Erasmus Medical Center, Department of Anesthesiology
• Public title: Fluvastatin and bisoprolol for the reduction of perioperative cardiac mortality and morbidity in high-risk patients undergoing non-cardiac surgery.
• Scientific title: Fluvastatin and bisoprolol for the reduction of perioperative cardiac mortality and morbidity in high-risk patients undergoing non-cardiac surgery. - DECREASE IV
• Date of first enrolment: 1/7/2004
• Target sample size: 6000
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=900
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Factorial; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: D. Poldermans

• Name: D. Poldermans

Key inclusion & exclusion criteria

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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Statin, Non-cardiac surgery, Beta-blocker, Perioperative cardiac complications

Intervention(s)

A computerised version of this scheme will be applied, which enables an automated check on all in- and exclusion criteria. According to the outcome of the risk-evaluation scheme, patients with a chance of more than 2% on perioperative cardiovascular death will undergo further cardiac evaluation, including ECG and/or stress myocardial testing. Patients with extensive myocardial ischemia are exluded. Participants will then be randomised according to an open-label, factorial design between (1) beta-blocker therapy (bisoprolol), (2) statin (fluvastatin), (3) combination of beta-blockers and statins (bisoporolol and fluvastatin) and (4) neither beta-blockers nor statins (control group). Study medication is started within 0-30 days prior to surgery and will be continued until 30 days after surgery.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

ISRCTN47637497

N/A

Source(s) of Monetary Support

Erasmus Medical Center, Department of Anesthesiology