LV Thrombus After Acute AMI: A Randomized Controlled Trial

This study is currently recruiting participants.
Verified March 2012 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Collaborators:
VU University of Amsterdam
Erasmus Medical Center
Information provided by (Responsible Party):
Jan Piek, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01556659
First received: March 12, 2012
Last updated: March 19, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556659

Contacts
Contact: Ronak Delewi, MD +31 (0) 205666405 r.delewi@amc.uva.nl
Contact: Mariella Hassell, MD +31 (0) 2056667883 m.e.hassell@amc.nl

Locations
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   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University of Amsterdam
Erasmus Medical Center
  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 April 17, 2014