Thrombus formation in the left chamber of the heart after an acute heart infarctio

• Conditions: eft Ventricular thrombus formation after acute myocardial infarction; MedDRA version: 14.0Level: LLTClassification code 10053755Term: Vitamin K antagonistSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-004265-32-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

The following exclusion criteria are applied:
1Younger than 18
2Clinically or hemodynamically unstable
3Treatment 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
4Previous stroke or transient ischemic attack
5Scheduled for major surgery (including CABG) during the course of the study
6Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists
7Contra-indication for vitamin K treatment
8Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study
9Congenital cardiac disease
10Presence of supraventricular or ventricular arrhythmias
11Expected candidate for ICD implantation with the next 6 months
12Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation
= 30mL/min)
13Known or symptomatic brain disease (e.g. brain tumor)
14Women who are pregnant.

15Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging i.e.:
•pacemaker
•cerebrovascular clips
•known contrast allergy
•claustrophobia
16Follow-up impossible (no fixed abode, etc)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1.composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism <br>2.occurrence of major and minor bleeding<br>3.presence of new cerebral mirco-bleeds<br>4.neurological status <br>5.quality of life. <br>;Timepoint(s) of evaluation of this end point: 6, 12 months and 5 year