Left Ventricular thrombus formation after acute myocardial infarction MedDRA version: 14.0 Level: LLT Classification code 10053755 Term: Vitamin K antagonist System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: acenocoumarol
Product Name: Acenocoumarol
Product Code: RVG 50674
Pharmaceutical Form: Oral drops
INN or Proposed INN: ACENOCOUMAROL
CAS Number: 152-72-7
Other descriptive name: LV thrombu
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
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 CrCl calculated by Cockcroft-Gault equation = 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to determine in a randomized fashion the risks as well as the benefits of the addition of vitamin K antagonists to dual anti-platelet therapy in patients with primary PCI-treated AMI and LV thrombus formation. ;Primary end point(s): The primary end point is defined as presence of new cerebral (micro-) infarcts at 6 months relative to baseline measured by MRI.;Timepoint(s) of evaluation of this end point: 6 months;Secondary Objective: For the first time patients will be evaluated post-MI simultaneously with both cardiovascular as well as cerebral MRI. Patients with LV thrombus will be screened specifically for the occurrence of cerebral micro-embolization. Micro-embolization is a potential late complication of acute MI and post-infarct pharmacological therapy in patients with LV thrombus should aim at the prevention of both major thrombo-embolic events as well as silent ischemic stroke. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism 2. occurrence of major and minor bleeding 3. presence of new cerebral mirco-bleeds 4. neurological status 5. quality of life. ;Timepoint(s) of evaluation of this end point: 6, 12 months and 5 year | — |
Countries
Netherlands
Contacts
Public Contactstudy-coordinator
Academic Medical Center
Outcome results
None listed