LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin
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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 |
- 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.
- 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 |
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 |
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
Contacts and 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 | |
| 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:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Myocardial Infarction Thrombosis Anterior Wall Myocardial Infarction Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Ischemia Pathologic Processes |
Necrosis Embolism and Thrombosis Heparin, Low-Molecular-Weight Warfarin Enoxaparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013