| - candidate number | 2456 |
| - NTR Number | NTR899 |
| - ISRCTN | ISRCTN83738615 |
| - Date ISRCTN created | 7-mrt-2007 |
| - date ISRCTN requested | 6-mrt-2007 |
| - Date Registered NTR | 12-feb-2007 |
| - Secondary IDs | N/A |
| - Public Title | Perioperative myocardial ischemia and cytokine response in patients undergoing high-risk surgery; the influence of fluvastatin. |
| - Scientific Title | Perioperative myocardial ischemia and cytokine response in patients undergoing high-risk surgery; the influence of fluvastatin. |
| - ACRONYM | DECREASE III |
| - hypothesis | The primary objective is to study the relation between fluvastatin therapy and the incidence of myocardial ischemia in patients undergoing high-risk surgery. The secondary objective is to study the perioperative cytokine response in relation to fluvastatine therapy in patients undergoing high-risk surgery. |
| - Healt Condition(s) or Problem(s) studied | Inflammation, Statin, Vascular surgery, Perioperative |
| - Inclusion criteria | 1. Age > 40 years; 2. Scheduled for elective noncardiac surgery; 3. Risk score for perioperative; 4. Cardiovascular death „d51 points; 5. Written informed consent. |
| - Exclusion criteria | 1. Currently on statin therapy; 2. Contraindication for statin therapy; 3. Scheduled for surgery which interferes with continuous 12-lead ECG recording, such as thoracic and upper abdominal surgery; 4. Unstable coronary disease; 5. Undergoing emergency surgery; 6. Patients with extensive stress-induced ischemia during dobutamine stress test; 7. CK at baseline > 10x 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jul-2004 |
| - planned closingdate | 1-jul-2007 |
| - Target number of participants | 500 |
| - Interventions | 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 randomized to fluvastatin XL 80 mg or placebo once daily from randomization, 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 ischemia, 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 1, 3, 7 after surgery or at discharge. |
| - Primary outcome | The primary endpoint is the occurrence of myocardial ischemia recorded during a 96-hour period using a 12-lead Rozing recorder. Ischemia is divided into pre, peri, and post-operative periods. The severity of ischemia in each period is scored as 'ischemic burden', reflecting the duration (minutes) and severity (ST-segment change from baseline) of ischemia. |
| - Secondary outcome | 1. Perioperative cytokine response. At screening, before the induction of anaesthesia, and after surgery cytokines are measured at 6, 24 hours after surgery, at 48, 72, and 96 hours after surgery; and 4, 5, 6, and 7 days after surgery; 2. Composite of cardiovascular death and myocardial infarction within 30 days after surgery. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Prof. dr. D. Poldermans |
| - CONTACT for SCIENTIFIC QUERIES | Prof. dr. D. Poldermans |
| - Sponsor/Initiator | Erasmus Medical Center, Department of Anesthesiology |
| - Funding (Source(s) of Monetary or Material Support) | Erasmus Medical Center, Department of Anesthesiology |
| - Publications | N/A |
| - Brief summary | This is a randomized, double-blind placebo controlled study evaluating the effect of fluvastatin XL 80 mg on perioperative cardiac ischemic events in patients undergoing major vascular noncardiac surgery. Patients will receive fluvastatin XL 80 mg (n=250) or placebo (n=250) from 30 days prior to surgery up to 30 days after surgery. The primary objective is to study the relation between fluvastatin therapy and the incidence of myocardial ischemia in patients undergoing high-risk surgery. The secondary objective is to study the perioperative cytokine response in relation to fluvastatine therapy in patients undergoing high-risk surgery. |
| - Main changes (audit trail) | |
| - RECORD | 12-feb-2007 - 3-dec-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl