NCT00321009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2000

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
Last Updated

May 3, 2006

Status Verified

May 1, 2006

First QC Date

May 1, 2006

Last Update Submit

May 1, 2006

Conditions

Coronary Artery DiseaseAcute Myocardial Infarction

Keywords

Myocardial InfarctionLeft Ventricular Mural ThrombusLow Molecular Weight HeparinEnoxaparinWarfarinEchocardiograms

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • What are the associated costs and length of hospital stay after randomized to

  • enoxaparin vs. warfarin?

Interventions

EnoxaparinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St Joseph's Health Center Dept. of Cardiology

Syracuse, New York, 13203, United States

Location

LaBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27403, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Cardiovascular Associates Ltd.

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Cindy L Grines, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

March 1, 2000

Study Completion

April 1, 2004

Last Updated

May 3, 2006

Record last verified: 2006-05

Locations

US(6)