Clinical trial
Left Ventricular Thrombus Formation After Acute Myocardial Infarction - a Randomized Multi-center Trial Comparing Two Different Anti-thrombotic Regimens
Name
2011-004265-32
Description
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).
Trial arms
Trial start
2012-03-01
Estimated PCD
2018-12-01
Trial end
2022-06-01
Status
Terminated
Treatment
Absence of vitamin K antagonist
Dual anti-platelet therapy
Arms:
vitamin K antagonist -
Other names:
warfarin
Size
25
Primary endpoint
The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.
6 months relative to baseline
Eligibility 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2024-04-25
1 organization
1 product
1 indication