Contact information
Type
Scientific
Primary contact
Prof D Poldermans
ORCID ID
Contact details
Erasmus Medical Centre
Department of Anesthesiology
Rotterdam
3015 GD
Netherlands
+31 (0)10 463 4613
d.poldermans@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR900
Study information
Scientific title
Acronym
DECREASE IV
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, factorial group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Non-cardiac surgery, perioperative cardiac complications
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Fluvastatin and bisoprolol
Primary outcome measures
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
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
Overall trial start date
01/07/2004
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant 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%
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
6000
Participant 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
Recruitment start date
01/07/2004
Recruitment end date
01/07/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15632892
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19474688
Publication citations
-
Protocol
Schouten O, Poldermans D, Visser L, Kertai MD, Klein J, van Urk H, Simoons ML, van de Ven LL, Vermeulen M, Bax JJ, Lameris TW, Boersma E, 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, 148, 6, 1047-1052, doi: 10.1016/j.ahj.2004.05.046.
-
Results
Dunkelgrun M, Boersma E, Schouten O, Koopman-van Gemert AW, van Poorten F, Bax JJ, Thomson IR, Poldermans D, , Bisoprolol and fluvastatin for the reduction of perioperative cardiac mortality and myocardial infarction in intermediate-risk patients undergoing noncardiovascular surgery: a randomized controlled trial (DECREASE-IV)., Ann. Surg., 2009, 249, 6, 921-926, doi: 10.1097/SLA.0b013e3181a77d00.