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ISRCTN
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ISRCTN83738615
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ClinicalTrials.gov identifier
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Public title
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Perioperative myocardial ischaemia and cytokine response in patients undergoing high-risk surgery: the influence of fluvastatin
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Scientific title
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Acronym
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DECREASE III
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Serial number at source
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NTR899
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Approval received from the Medical Ethics Review Committees Erasmus MC (Medische Ethische Toetsings Commissie Erasmus MC) (ref: MEC 238.71/2004/10).
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Study design
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Randomised double blind placebo controlled parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Perioperative myocardial ischaemia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2004
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Anticipated end date
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01/07/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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
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Sources of funding
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Erasmus Medical Centre (Netherlands)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19726772
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Contact name
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Prof
D
Poldermans
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Address
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Erasmus Medical Centre
Department of Anesthesiology
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City/town
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Rotterdam
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Zip/Postcode
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3015 GD
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Country
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Netherlands
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Tel
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+31 (0)10 463 4613
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Email
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d.poldermans@erasmusmc.nl
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Sponsor
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Erasmus Medical Centre (Netherlands)
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Address
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Department of Anesthesiology
P.O. Box 2040
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City/town
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Rotterdam
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Zip/Postcode
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3000 CA
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Country
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Netherlands
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Sponsor website:
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http://www.erasmusmc.nl/
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Date applied
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07/03/2007
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Last edited
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24/11/2011
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Date ISRCTN assigned
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07/03/2007
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