LV thrombus formation
Conditions
Interventions
After written informed consent has been obtained, echocardiography and MRI are
performed within 8 weeks after PCI. When LV thrombus is present on baseline
MRI, patients are randomized to
1) Triple
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints as assessed at 6 and 12 months are: • the composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism • presence of new cerebral mirco-bleeds • the occurrence of major and minor bleeding • neurological status and quality of life. | — |
Countries
Netherlands
Outcome results
None listed