LV Thrombus After Acute AMI: A Randomized Controlled Trial

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Left Ventricular (LV) thrombus formation is witnessed in at least 10% of patients with ST segment elevation myocardial infarction (STEMI). It is a feared complication since it might increase the risk of thrombo-embolic events, including stroke. Guidelines recommend vitamin K antagonist treatment in these patients. However patients with STEMI nowadays undergo primary percutaneous coronary intervention (PCI) with coronary stent placement and consequently require dual anti-platelet therapy (ascal and P2Y12 inhibitors) to prevent stent thrombosis. Consequently, STEMI patients with LV thrombus are currently treated with triple antithrombotic therapy (aspirin, P2Y12 inhibitors, e.g. clopidogrel (75 mg/d) and vitamin K antagonist). Patients treated with triple antithrombotic therapy are subject to a strongly increased bleeding risk with a yearly incidence of 3.7% for dual anti-platelet therapy as compared to 12% for triple antithrombotic therapy. About 10% of these bleedings are cerebral. The mortality of such haemorrhagic strokes is 25%. A recent retrospective analysis did not show any beneficial effects of addition of vitamin K antagonist to dual anti-platelet therapy to prevent stroke. If vitamin K antagonist-therapy could be omitted, morbidity and mortality due to post-PCI bleedings will decrease. Therefore, a randomized trial is warranted to address this issue.

Design: A multicenter, prospective, randomized, two non-inferiority trial. The objective of the study is to determine in a randomized fashion the risks and benefits of the addition of vitamin K antagonists to dual anti-platelet therapy or dual anti-platelet therapy in patients with PCI-treated STEMI and LV thrombus formation on baseline echocardiography or baseline Magnetic Resonance Imaging (MRI).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Erasmus Medical Center; VU University of Amsterdam
• Treatments: Acenocoumarol

Criteria

Inclusion Criteria:

• Suspected Left Ventricular thrombus on echocardiography or routine Magnetic Resonance Imaging

• Ongoing treatment with dual antiplatelet therapy according to ESC/ACC-AHA guidelines at the time of randomization.

Exclusion Criteria:

• Younger than 18

• Clinically or hemodynamically unstable

• 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

• Previous stroke or transient ischemic attack

• Scheduled for major surgery (including Coronary Artery Bypass Grafting) during the course of the study

• Active bleeding or high risk for bleeding contraindicating treatment with vitamin K antagonists

• Contra-indication for vitamin K antagonist treatment

• Chronic treatment with NSAIDs or COX-2 inhibitors for more than 4 days per week anticipated to continue during the study

• Congenital cardiac disease

• Presence of supraventricular or ventricular arrhythmias

• Expected candidate for ICD implantation with the next 6 months

• Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation 5 30mL/min)

• Known or symptomatic brain disease (such as brain tumor)

• Women who are pregnant.

• Any contraindication for Contrast-Enhanced Magnetic Resonance Imaging (such as pacemaker, cerebrovascular clips, known contrast allergy, claustrophobia)

• Follow-up impossible (for example no fixed abode)