The Rotterdam Antiplatelet Therapy in Vascular Patients Study
Suspended
- Conditions
- Patients who undergo vascular surgery for abdominal aneurysm or peripheral artery disease who have myocardial injury (e.g. hsTnT release) before and after the procedure. Patienten die een ingreep ondergaan in verband met een abdominaal aneurysma of perifeer arterieel vaatlijden, met myocard schade (gedefinieerd als hsTnT stijging) voor en na de ingreep.
- Registration Number
- NL-OMON28641
- Lead Sponsor
- Erasmus Medical Center Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 100
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to assess the efficacy of clopidogrel, as compared to placebo, on top of standard treatment with aspirin on; <br /><br>A. the composite endpoint of MACE, defined as;<br /><br>- cardiovascular death<br /><br>- non-fatal myocardial infarction<br /><br>- stroke<br /><br>- severe ischemia of the coronary or peripheral arterial circulation leading to intervention<br>
- Secondary Outcome Measures
Name Time Method Secondary objectives include determining the efficacy of clopidogrel, compared to placebo, on top of standard treatment with aspirin on; <br /><br>B. Individual components of MACE <br /><br>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.<br><br /><br /><br>Tertiary objectives include determining; <br /><br>D. Presence of significant coronary artery disease and the impact of presence of vulnerable plaques according to PROSPECT criteria <br><br>