E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Study target patients are those with peripheral arterial disease who underwent a major vascular surgery and develop asymptomatic troponine-elevation. These patients are randomised for treatment with clopidogrel or not. Main aim of the study is prevention of cardiac events in pt with peripheral arterial disease. Follow-up is directed at occurrence of cardiovascular events and post-operative bleeding complications. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10034638 |
E.1.2 | Term | Peripheral vascular disorders NEC |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018106 |
E.1.2 | Term | Generalized arterial disease |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to determine whether clopidogrel + best medical treatment is superior to best medical treatment only in preventing: A. cardiovascular death, MI, stroke, or severe ischemia of the coronary or peripheral arterial circulation leading to an intervention. in patients with asymptomatic perioperative troponin release during or shortly (within 30days) after major vascular surgery. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives:Secondary objectives include determining the effect of clopidogrel on: B.Bleeding complications, defined as life-threatening bleeding, moderate and minor bleeding. In patients with asymptomatic perioperative troponin release after major vascular surgery. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria Men and women who are scheduled for major vascular surgery are eligible for the trial.Eligible patients include those above the age of 18 years and at least one of the following: 1. abdominal aortic aneurysm repair 2. aortic stenosis repair 3. above knee femoropopliteal bypass surgery 4. below knee femoropopliteal bypass surgery. And with postoperative asymptomatic troponin T release without ECG abnormalities. |
|
E.4 | Principal exclusion criteria |
Exclusion Criteria Potential subjects will be excluded with any of the following : 1. Active bleeding 2. Untreated left main disease 3. Active cardiac condition such as unstable angina pectoris, active CHF, serious cardiac arrhythmias, symptomatic valvular disease, recent < 6 months. 4. Preoperative positive troponin T 5. Inability to take clopidogrel orally 6. clear indication for long-term clopidogrel use 7. previous allergy or intolerance to clopidogrel 8. renal failure requiring dialysis 9. significant liver disease (i.e. ALAT, ASAT >3x ULN) 10. cancer with an expected life expectancy < 6 months 11. anticipated non-adherence to clopidogrel 12. excessive alcohol use 13. pregnancy or planning to become pregnant 14. failure to provide informed consent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is defined as the composite of cardiovascular death, MI, stroke, or severe ischemia of the coronary or peripheral arterial circulation leading to an intervention. Safety outcomes include life-threatening, moderate bleeding, and minor bleeding are considered as secondary outcome. Tertiary objectives include identification of preoperative risk factors and novel biomarkers of the primary endpoint. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Patients will be followed daily throughout hospitalization and require outpatient clinic visits at Day 30, and at 3, 6, and 12 months after surgery. Telephone and/or written follow-up will occur at 18 and 24 months after surgery. After 12 months the study medication will be stopped, unless there is another medical reason for continuation of the study medication |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |