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

ISRCTN	ISRCTN47637497
DOI	https://doi.org/10.1186/ISRCTN47637497
Protocol serial number	NTR900
Sponsor	Erasmus Medical Centre (Netherlands)
Funder	Erasmus Medical Centre (Netherlands)

Submission date: 07/03/2007
Registration date: 07/03/2007
Last edited: 24/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof D Poldermans
Scientific

Erasmus Medical Centre
Department of Anesthesiology
Rotterdam
3015 GD
Netherlands

Phone	+31 (0)10 463 4613
Email	d.poldermans@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, factorial group, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DECREASE IV
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Fluvastatin and bisoprolol
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.
Key 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
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	6000
Key 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%
Key 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
Date of first enrolment	01/07/2004
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Centre

Rotterdam
3015 GD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No
Protocol article	protocol	01/12/2004		Yes	No