LV Thrombus After Acute AMI: A Randomized Controlled Trial

April 24, 2024 updated by: Jan Piek, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Left Ventricular Thrombus Formation After Acute Myocardial Infarction - a Randomized Multi-center Trial Comparing Two Different Anti-thrombotic Regimens

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: vitamin K antagonist +
Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day) and vitamin K antagonist (acenocoumarol)
Active Comparator: vitamin K antagonist -
Treatment with carbasalaatcalcium 100 mg/day, P2Y12 inhibitors (clopidogrel 1x 75mg, ticagrelor 2x 90 mg or prasugrel 1x 10mg/day)
Drug: Absence of vitamin K antagonist
Dual anti-platelet therapy
Other Names:
  • warfarin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
6 months relative to baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
The presence of new cerebral micro-bleeds assessed by MRI
Time Frame: At 6 months and 12 months relative to baseline
At 6 months and 12 months relative to baseline
Occurrence of major and minor bleeding
Time Frame: At 6 and 12 months relative to baseline
At 6 and 12 months relative to baseline
Neurological status
Time Frame: At 6 and 12 months relative to baseline
At 6 and 12 months relative to baseline
Composite of vascular death, recurrent myocardial infarction, stroke or systemic embolism
Time Frame: At 6 and 12 months relative to baseline
At 6 and 12 months relative to baseline
Quality of life using a validated checklist
Time Frame: At 6 and 12 months relative to baseline
At 6 and 12 months relative to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Erasmus Medical Center
VU University of Amsterdam

Investigators

  • Principal Investigator: Jan J Piek, Prof, PI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

March 12, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimated)

March 16, 2012

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-004265-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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