|- candidate number||24576|
|- NTR Number||NTR5958|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-jul-2016|
|- Secondary IDs||NL54577.078.16 |
|- Public Title||The Rotterdam Antiplatelet Therapy in Vascular Patients Study |
|- Scientific Title||The Rotterdam Antiplatelet Therapy in Vascular Patients Study |
|- hypothesis||Long-term mortality after vascular surgery in high-risk patients can be explained through atherothrombotic events en therefore be treated with adequate antithrombotic therapy.|
|- Healt Condition(s) or Problem(s) studied||Abdominal Aortic Aneurysm (AAA), Peripheral Arterial Disease, Myocardial ischemia|
|- Inclusion criteria||1. Preoperative myocardial injury (baseline value), defined as hsTnT release > 14 ng/L.|
2. Absence of significant occlusive coronary artery disease as diagnosed through angiography (and confirmed by FFR).
3. Postoperative myocardial injury, defined as hsTnT release > 14 ng/L, which exceed the baseline value.
|- Exclusion criteria||Potential subjects will be excluded with any of the following;|
1. If event (i.e. hsTnT elevation) is diagnosed as myocardial infarction by cardiologist.
2. Presence of significant occlusive coronary artery disease, as diagnosed through preoperative angiography, requiring treatment.
3. No postoperative hsTnT values above the clinical reference of 14 ng/L and no rise with respect to baseline value.
4. Active bleeding.
5. Active cardiac conditions at the time of randomization such as unstable angina pectoris, active congestive heart failure (CHF), serious cardiac arrhythmias, symptomatic valvular disease.
6. Clear indication for long-term P2Y12 inhibitor use.
7. Preoperative use of P2Y12 inhibitors.
8. Previous allergy or intolerance to clopidogrel.
9. Use of oral anticoagulants after surgery.
10. Use of intravenous glycoprotein IIB/IIIA receptor inhibitors in the previous three days.
11. Coronary revascularization therapy in the previous six months.
12. Renal failure requiring dialysis.
13. Significant liver disease (i.e. ALAT, ASAT > 3x ULN).
14. Cancer with an expected life expectancy less than 6 months.
15. Excessive alcohol use.
16. No informed consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2016|
|- planned closingdate||1-jul-2018|
|- Target number of participants||100|
|- Interventions||Clopidogrel or placebo on top of standard treatment with aspirin|
|- Primary outcome||The primary objective is to assess the efficacy of clopidogrel, as compared to placebo, on top of standard treatment with aspirin on; |
A. the composite endpoint of MACE, defined as;
- cardiovascular death
- non-fatal myocardial infarction
- severe ischemia of the coronary or peripheral arterial circulation leading to intervention
|- Secondary outcome||Secondary objectives include determining the efficacy of clopidogrel, compared to placebo, on top of standard treatment with aspirin on; |
B. Individual components of MACE
C. Safety of clopidogrel, in terms of bleeding complications, defined as life-threatening bleeding, moderate and minor bleeding, postoperatively and during long-term follow-up.
Tertiary objectives include determining;
D. Presence of significant coronary artery disease and the impact of presence of vulnerable plaques according to PROSPECT criteria
|- Timepoints||T=0: eligibility screening at outpatient clinic visit|
T=1: CAG performance to evaluate cardiac risk
T=2a: Vascular Surgery
T=2b: Patient Randomization to study medication
T=3: 30 days after surgery -> first follow-up visit
T=5: 3 months after surgery -> second follow-up visit
T=8: 6 months after surgery -> third follow-up visit
T=11: 9 months after surgery -> fourth follow-up visit
T=14: 12 months after surgery -> fifth follow-up visit
End of study after 1 year of treatment.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Kristin Mol|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. Felix Lier, van|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Stichting Lijf en Leven|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||6-jul-2016 - 15-dec-2017|