LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

May 1, 2006 updated by: William Beaumont Hospitals

A Prospective Randomized Trial Comparing Enoxaparin to Warfarin for the Prevention of LV Thrombus Formation After Anterior Wall Myocardial Infarction: A 60 Patient Pilot Study

To prospectively evaluate the utility of enoxaparin vs. oral warfarin in reduction of echocardiographic indices of LV mural thrombus. The primary outcome is the presence of LV mural thrombus at 3.5 months. The secondary outcome is cost analysis comparing the two arms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with anterior Q-wave MIs and ejection fractions<=40% will be enrolled within the first 4 days of infarction. Patients will be randomized to receive either enoxaparin 1mg/kg (maximum 100mg) subcutaneously every 12 hours for one month or heparin followed by oral warfarin for 3 months.

Clinical and safety evaluations, 2-D echocardiograms at baseline and at 3.5 months and cost analysis will be performed.

Study Type

Interventional

Enrollment

60

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • New York
      • Syracuse, New York, United States, 13203
        • St Joseph's Health Center Dept. of Cardiology
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • LaBauer Cardiovascular Research Foundation
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Hospital
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Cardiovascular Associates Ltd.

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 80

  • Anterior myocardial infarction with:

    1. Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new
    2. CK peak>5 times the upper limit of normal with positive MB bands
  • Ejection fraction <=40% or anterior dyskinesis or documented LV Thrombus
  • MI onset < 7 days from randomization

Exclusion Criteria:

  • Inability to give written informed consent
  • Medical conditions that would prohibit discharge within 48 hours with the exception of need for anticoagulation
  • Cardiogenic shock, rest angina unresponsive to medical therapy or serious ventricular arrhythmia in the 24 hours prior to randomization
  • Patients scheduled for surgical procedure in the next 4 months that would prevent use of enoxaparin or warfarin
  • Anemia: Baseline Hgb<=9 gm for women, <=10 gm for men or platelet count<100,000
  • Renal insufficiency (creatinine >2.0 mg/dl)
  • Serious liver disease as reflected by INR>1.3
  • Stroke within past 6 months or a prior documented intracranial or subarachnoid hemorrhage
  • Active bleeding or major surgery within 2 weeks prohibiting the use of anticoagulants
  • Acute pericarditis
  • Women of childbearing potential unless pregnancy test negative
  • Cardiac or non-cardiac condition with expected survival< 6 months
  • Severe peripheral vascular disease
  • Patients who undergo cardiac surgery, including CABG, as a result of their index myocardial infarction
  • Allergy to aspirin, heparin or warfarin, pork or pork products
  • History of recurrent thromboembolic disease or a history of Protein C, Protein S, antithrombin III deficiency or known bleeding disorder.
  • Current use of warfarin or need for chronic anticoagulation
  • Current participation in other trials using investigational drugs or devices
  • Prior enrollment in this trial

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
What is the incidence of LV mural thrombus with administration of enoxaparin vs.
warfarin at 3.5 months in patients presenting with anterior wall myocardial
infarctions.

Secondary Outcome Measures

Outcome Measure
What are the associated costs and length of hospital stay after randomized to
enoxaparin vs. warfarin?

Collaborators and Investigators

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

Sponsor

William Beaumont Hospitals

Collaborators

Rhone-Poulenc Rorer

Investigators

  • Principal Investigator: Cindy L Grines, MD, William Beaumont Hospitals

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

March 1, 2000

Study Completion

April 1, 2004

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

May 3, 2006

Last Update Submitted That Met QC Criteria

May 1, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 59673

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.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Enoxaparin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe