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LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

Primary Purpose

Coronary Artery Disease, Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Myocardial Infarction, Left Ventricular Mural Thrombus, Low Molecular Weight Heparin, Enoxaparin, Warfarin, Echocardiograms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 to 80 Anterior myocardial infarction with: Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new 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

Sites / Locations

  • University of Colorado Health Sciences Center
  • William Beaumont Hospital
  • St Joseph's Health Center Dept. of Cardiology
  • LaBauer Cardiovascular Research Foundation
  • Doylestown Hospital
  • Cardiovascular Associates Ltd.

Outcomes

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?

Full Information

First Posted
May 1, 2006
Last Updated
May 1, 2006
Sponsor
William Beaumont Hospitals
Collaborators
Rhone-Poulenc Rorer
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1. Study Identification

Unique Protocol Identification Number
NCT00321009
Brief Title
LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
William Beaumont Hospitals
Collaborators
Rhone-Poulenc Rorer

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Myocardial Infarction
Keywords
Myocardial Infarction, Left Ventricular Mural Thrombus, Low Molecular Weight Heparin, Enoxaparin, Warfarin, Echocardiograms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Primary Outcome Measure Information:
Title
What is the incidence of LV mural thrombus with administration of enoxaparin vs.
Title
warfarin at 3.5 months in patients presenting with anterior wall myocardial
Title
infarctions.
Secondary Outcome Measure Information:
Title
What are the associated costs and length of hospital stay after randomized to
Title
enoxaparin vs. warfarin?

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 Anterior myocardial infarction with: Pathological Q-waves in at least 3 contiguous anterior precordial leads, assumed to be new 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy L Grines, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
St Joseph's Health Center Dept. of Cardiology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Facility Name
LaBauer Cardiovascular Research Foundation
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Cardiovascular Associates Ltd.
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

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LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

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