LV Thrombus After Acute AMI: A Randomized Controlled Trial
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Ventricular Thrombosis Mural Following Myocardial Infarction |
Drug: Absence of Acenocoumarol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Left Ventricular Thrombus Formation After Acute Myocardial Infarction - a Randomized Multi-center Trial Comparing Two Different Anti-thrombotic Regimens |
- The proportions of patients with new cerebral micro-infarcts at 6 months relative to baseline measured by MRI. [ Time Frame: 6 months relative to baseline ] [ Designated as safety issue: No ]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.
- The presence of new cerebral micro-bleeds assessed by MRI [ Time Frame: At 6 months and 12 months relative to baseline ] [ Designated as safety issue: Yes ]
- Occurrence of major and minor bleeding [ Time Frame: At 6 and 12 months relative to baseline ] [ Designated as safety issue: Yes ]
- Neurological status [ Time Frame: At 6 and 12 months relative to baseline ] [ Designated as safety issue: No ]
- Quality of life. [ Time Frame: At 6 and 12 months relative to baseline ] [ Designated as safety issue: No ]
- Composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism [ Time Frame: At 6 and 12 months relative to baseline ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Triple antithrombotic therapy
Treatment with aspirin, P2Y12 inhibitors and vitamin K antagonist.
|
Drug: Absence of Acenocoumarol
Dual anti-platelet therapy without the addition of Acenocoumarol.
|
|
No Intervention: Triple anti-thrombotic therapy
Treatment with aspirin, P2Y12 inhibitors and vitamin K antagonist.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Ronak Delewi, MD | +31 (0) 205666405 | r.delewi@amc.uva.nl |
| Contact: Mariella Hassell, MD | +31 (0) 2056667883 | m.e.hassell@amc.nl |
| Netherlands | |
| Academic Medical Center | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Contact: Mariella ECJ Hassell, MD +31 (0) 2056667883 m.e.hassell@amc.nl | |
| Contact: Ronak Delewi, MD +31 (0) 205666405 r.delewi@amc.uva.nl | |
More Information
No publications provided
| Responsible Party: | Jan Piek, Clinical Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| ClinicalTrials.gov Identifier: | NCT01556659 History of Changes |
| Other Study ID Numbers: | 2011-004265-32 |
| Study First Received: | March 12, 2012 |
| Last Updated: | March 19, 2012 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
|
Left ventricular thrombus Acute myocardial infarction Anticoagulation |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Thrombosis Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Vascular Diseases Embolism and Thrombosis Acenocoumarol Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013