LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321009
• Other study ID #: IND 59673
• Status: Completed
• Phase: N/A
• First received: May 1, 2006
• Last updated: May 1, 2006
• Start date: March 2000
• Est. completion date: April 2004

Study information

• Verified date: May 2006
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Anterior Wall Myocardial Infarction
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Drug:
• Enoxaparin

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	LaBauer Cardiovascular Research Foundation	Greensboro	North Carolina
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	St Joseph's Health Center Dept. of Cardiology	Syracuse	New York
United States	Cardiovascular Associates Ltd.	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	Rhone-Poulenc Rorer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What is the incidence of LV mural thrombus with administration of enoxaparin vs.
Primary	warfarin at 3.5 months in patients presenting with anterior wall myocardial
Primary	infarctions.
Secondary	What are the associated costs and length of hospital stay after randomized to
Secondary	enoxaparin vs. warfarin?