Condition category
Surgery
Date applied
07/03/2007
Date assigned
07/03/2007
Last edited
24/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes