LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

This study has been completed.
Sponsor:
Collaborator:
Rhone-Poulenc Rorer
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00321009
First received: May 1, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Acute Myocardial Infarction
Drug: Enoxaparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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:
  • What are the associated costs and length of hospital stay after randomized to
  • enoxaparin vs. warfarin?

Estimated Enrollment: 60
Study Start Date: March 2000
Estimated Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321009

Locations
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New York
St Joseph's Health Center Dept. of Cardiology
Syracuse, New York, United States, 13203
United States, North Carolina
LaBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States, 27403
United States, Pennsylvania
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
United States, Virginia
Cardiovascular Associates Ltd.
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
William Beaumont Hospitals
Rhone-Poulenc Rorer
Investigators
Principal Investigator: Cindy L Grines, MD William Beaumont Hospitals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00321009     History of Changes
Other Study ID Numbers: IND 59673
Study First Received: May 1, 2006
Last Updated: May 1, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by William Beaumont Hospitals:
Myocardial Infarction
Left Ventricular Mural Thrombus
Low Molecular Weight Heparin
Enoxaparin
Warfarin
Echocardiograms

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Anterior Wall Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Arteriosclerosis
Arterial Occlusive Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014