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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21523

Enrollment

6000

Registered

2007-02-12

Start date

2004-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-cardiac surgery

Interventions

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 chanc

Eligibility

Inclusion 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: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactD. Poldermans

Erasmus MC Department of Anesthesiology

d.poldermans@erasmusmc.nl+31 10 4634613

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)