LV Thrombus After Acute AMI: A Randomized Controlled Trial
- Conditions
- Ventricular Thrombosis Mural Following Myocardial Infarction
- Interventions
- Drug: Absence of vitamin K antagonist
- Registration Number
- NCT01556659
- Brief 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).
- Detailed Description
Design: A multicenter, prospective, randomized, non-inferiority trial with blinded evaluation of endpoints
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 PCI-treated STEMI and LV thrombus formation
Patients: Patients with acute myocardial infarction treated with primary PCI and LV thrombus on baseline echocardiography or baseline Magnetic Resonance Imaging. (MRI)
Methods: After written informed consent has been obtained, echocardiography and MRI are performed between 7-12 days after PCI. When LV thrombus is present on baseline MRI, patients are randomized to
1. Triple antithrombotic therapy (aspirin (100 mg/d), thienopyridine class antiplatelet agent,) and vitamin K antagonist (goal INR is 2.0 to 3.0))
2. Dual anti-platelet therapy (aspirin (100mg/d) and thienopyridine class antiplatelet agent, e.g. clopidogrel (75 mg/d).
Primary Endpoint: Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI.
Secondary Endpoints: 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vitamin K antagonist - Absence of vitamin K antagonist Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day)
- Primary Outcome Measures
Name Time Method The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI. 6 months relative to baseline Primary outcome is defined as the proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by Magnetic Resonance Imaging.
- Secondary Outcome Measures
Name Time Method The presence of new cerebral micro-bleeds assessed by MRI At 6 months and 12 months relative to baseline Occurrence of major and minor bleeding At 6 and 12 months relative to baseline Quality of life using a validated checklist At 6 and 12 months relative to baseline Neurological status At 6 and 12 months relative to baseline Composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism At 6 and 12 months relative to baseline
Trial Locations
- Locations (1)
Academic Medical Center
🇳🇱Amsterdam, Netherlands