eft Ventricular Thrombus Formation after Acute Myocardial Infarction - a randomized multi-center trial comparing 2 different anti-thrombotic regimens
- Conditions
- LV thrombus formation10082206
- Registration Number
- NL-OMON43624
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 650
1.Suspected LV thrombus on echocardiography or routine MRI ;2.Ongoing treatment with dual antiplatelet therapy (e.g. ASA and clopidogrel) at the time of;randomization
The following exclusion criteria are applied:;1 Younger than 18 ;2 Clinically or hemodynamically unstable;3 Treatment with vitamin K antagonist prior to PCI or other expected indication for vitamin K antagonist treatment (e.g. atrium fibrillation) within the next 6 months;4 Previous stroke or transient ischemic attack ;5 Scheduled for major surgery (including CABG) during the course of the study;6 Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists;7 Contra-indication for vitamin K treatment;8 Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study;9 Congenital cardiac disease;10 Presence of supraventricular or ventricular arrhythmias;11 Expected candidate for ICD implantation with the next 6 months;12 Severe renal impairment (estimated glomerular filtration rate (eGFR) <= 30mL/min);13 Known or symptomatic brain disease (e.g. brain tumor);14 Women who are pregnant. ;15 Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging i.e.:;• pacemaker;• cerebrovascular clips ;• known contrast allergy;• claustrophobia;16 Follow-up impossible (no fixed abode, etc)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is defined as the proportions of patients with new cerebral<br /><br>micro-infarcts at 6 months relative to baseline measured by MRI.<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints as assessed at 6 and 12 months are:<br /><br>• the composite of vascular death, recurrent myocardial infarction, stroke or<br /><br>systemic embolism<br /><br>• presence of new cerebral mirco-bleeds<br /><br>• the occurrence of major and minor bleeding<br /><br>• neurological status and quality of life.</p><br>