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 |
| Secondary identifying numbers | NTR900 |
- 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
Scientific
Erasmus Medical Centre
Department of Anesthesiology
Rotterdam
3015 GD
Netherlands
| Phone | +31 (0)10 463 4613 |
|---|---|
| d.poldermans@erasmusmc.nl |
Study information
| Study design | Randomised, active controlled, factorial group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluvastatin and bisoprolol |
| Primary outcome measure | 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 study start date | 01/07/2004 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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
3015 GD
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Website | http://www.erasmusmc.nl/ |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Hospital/treatment centre
Erasmus Medical Centre (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2004 | Yes | No | |
| Results article | results | 01/06/2009 | Yes | No |
