LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

NCT ID: NCT00321009

Last Updated: 2006-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2004-04-30

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.

Conditions

Coronary Artery Disease; Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Enoxaparin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhone-Poulenc Rorer

INDUSTRY

Sponsor Role: collaborator

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Principal Investigators

Cindy L Grines, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

University of Colorado Health Sciences Center

Denver, Colorado, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

St Joseph's Health Center Dept. of Cardiology

Syracuse, New York, United States

LaBauer Cardiovascular Research Foundation

Greensboro, North Carolina, United States

Doylestown Hospital

Doylestown, Pennsylvania, United States

Cardiovascular Associates Ltd.

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

IND 59673

Identifier Type: -

Identifier Source: org_study_id