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Fluvastatin and bisoprolol for the reduction of perioperative cardiac mortality and morbidity in high-risk patients undergoing non-cardiac surgery
DOI 10.1186/ISRCTN47637497
ClinicalTrials.gov identifier
EudraCT number
Public title Fluvastatin and bisoprolol for the reduction of perioperative cardiac mortality and morbidity in high-risk patients undergoing non-cardiac surgery
Scientific title
Serial number at source NTR900
Study hypothesis The general objective of the DECREASE-IV trial is to assess the clinical efficacy of beta-blocker therapy, statin therapy and combination therapy with beta-blockers and statins in patients undergoing major non-cardiac surgery.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised, active controlled, factorial group, multicentre trial
Countries of recruitment Netherlands
Disease/condition/study domain Non-cardiac surgery, perioperative cardiac complications
Participants - 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%
Participants - 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
Anticipated start date 01/07/2004
Anticipated end date 01/07/2008
Status of trial Completed
Patient information material
Target number of participants 6000
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 chance of more than 2% on perioperative cardiovascular death will undergo further cardiac evaluation, including Electrocardiogram (ECG) and/or stress myocardial testing. Patients with extensive myocardial ischaemia 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 (bisoprolol and fluvastatin)
4. Neither beta-blockers nor statins (control group)

Study medication is started within zero to 30 days prior to surgery and will be continued until 30 days after surgery.
Primary outcome measure(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 Myocardial Infarction (MI), in moderate and high risk patients undergoing non-cardiac surgery.
Secondary outcome measure(s) 1. To determine the impact of perioperative administration of bisoprolol and/or fluvastatin on:
1.1. the incidence of total mortality, cardiovascular death, and non-fatal myocardial infarction during one year follow-up
1.2. the length of hospital stay, and length of Intensive Care Unit (ICU)/Critical Care Unit (CCU) stay
1.3. the 30-day incidence of clinically significant cardiac arrhythmias and heart failure and the need for coronary revascularisation procedures
2. The DECREASE-IV trial has five safety objectives, namely to determine the impact of the different treatments on:
2.1. the 30-day congestive heart failure
2.2. the 30-day incidence of clinically significant bradycardia
2.3. the 30-day incidence of clinically significant hypotension
2.4. the 30-day incidence of clinically significant liver dysfunction
2.5. the occurence of myopathy
Sources of funding Erasmus Medical Centre (Netherlands)
Trial website
Publications 1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15632892
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19474688
Contact name Prof  D  Poldermans
  Address Erasmus Medical Centre
Department of Anesthesiology
  City/town Rotterdam
  Zip/Postcode 3015 GD
  Country Netherlands
  Tel +31 (0)10 463 4613
  Email d.poldermans@erasmusmc.nl
Sponsor Erasmus Medical Centre (Netherlands)
  Address Department of Anesthesiology
P.O. Box 2040
  City/town Rotterdam
  Zip/Postcode 3000 CA
  Country Netherlands
  Sponsor website: http://www.erasmusmc.nl/
Date applied 07/03/2007
Last edited 24/11/2011
Date ISRCTN assigned 07/03/2007
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