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

NTR899

Study information

Scientific title

Acronym

DECREASE III

Study hypothesis

The primary objective is to study the relation between fluvastatin therapy and the incidence of myocardial ischaemia in patients undergoing high-risk surgery. The secondary objective is to study the perioperative cytokine response in relation to fluvastatin therapy in patients undergoing high-risk surgery.

Ethics approval

Approval received from the Medical Ethics Review Committees Erasmus MC (Medische Ethische Toetsings Commissie Erasmus MC) (ref: MEC 238.71/2004/10).

Study design

Randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Perioperative myocardial ischaemia

Intervention

Patients will come for an outpatient visit (= screening) approximately 30 days (= mean) prior to surgery. Informed consent will then be signed and in- and exclusion criteria will be checked. If the patient is eligible for the study, the patient will be randomised and subsequently study medication will be dispensed.

Patients will be randomised to fluvastatin XL 80 mg or placebo once daily from randomisation, approximately one month prior to surgery, to 30 days after surgery. A computer generated random number list will be used to randomise patients. All randomised patients are irrevocably in the study. They will be followed and analysed in the group to which they are allocated, regardless of whether or not they receive the assigned treatment or fulfil the eligibility criteria.

The primary endpoint, myocardial ischaemia, will be measured by continuous 12-lead ECG recording, starting on the evening prior to surgery up to 72 hours after surgery. Furthermore troponin release will be assessed on day one, three, seven after surgery or at discharge.

Intervention type

Drug

Phase

Not Specified

Drug names

Fluvastatin

Primary outcome measures

The primary endpoint is the occurrence of myocardial ischaemia recorded during a 96-hour period using a 12-lead Rozing recorder. Ischaemia is divided into pre-, peri-, and post-operative periods. The severity of ischaemia in each period is scored as 'ischaemic burden', reflecting the duration (minutes) and severity (ST-segment change from baseline) of ischaemia.

Secondary outcome measures

1. Perioperative cytokine response. At screening, before the induction of anaesthesia, and after surgery cytokines are measured at six, 24, 48, 72, and 96 hours after surgery; and four, five, six, and seven days after surgery
2. Composite of cardiovascular death and myocardial infarction within 30 days after surgery

Overall trial start date

01/07/2004

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than 40 years
2. Scheduled for elective noncardiac surgery
3. Risk score for perioperative cardiovascular death greater than or equal to 51 points
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

1. Currently on statin therapy
2. Contraindication for statin therapy
3. Scheduled for surgery which interferes with continuous 12-lead Electrocardiogram (ECG) recording, such as thoracic and upper abdominal surgery
4. Unstable coronary disease
5. Undergoing emergency surgery
6. Patients with extensive stress-induced ischaemia during dobutamine stress test
7. Creatine Kinase (CK) at baseline greater than 10 x Upper Limit of Normal (ULN)
8. Previous participation in the fluvastatin-study
9. Reoperation within 30 days of an initial surgical procedure
10. Participation in another clinical trial within the last 30 days

Recruitment start date

01/07/2004

Recruitment end date

01/07/2007

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19726772

Publication citations

  1. Results

    Schouten O, Boersma E, Hoeks SE, Benner R, van Urk H, van Sambeek MR, Verhagen HJ, Khan NA, Dunkelgrun M, Bax JJ, Poldermans D, , Fluvastatin and perioperative events in patients undergoing vascular surgery., N. Engl. J. Med., 2009, 361, 10, 980-989, doi: 10.1056/NEJMoa0808207.

Additional files

Editorial Notes