Coronary Artery DiseaseNCT00321009
LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin
A study testing Enoxaparin in people with Coronary Artery Disease and Acute Myocardial Infarction, run by Corewell Health East at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Acute Myocardial Infarction
- What is being tested?
- Enoxaparin
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2000to Apr 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 19Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Health Sciences Center
Denver, Colorado, 80262
Doylestown Hospital
Doylestown, Pennsylvania, 18901
LaBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27403
William Beaumont Hospital
Royal Oak, Michigan, 48073
St Joseph's Health Center Dept. of Cardiology
Syracuse, New York, 13203
Cardiovascular Associates Ltd.
Virginia Beach, Virginia, 23454
About this study
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
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.
Read the 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.
- Being tested
- Enoxaparin
- Keywords
- Myocardial Infarction, Left Ventricular Mural Thrombus, Low Molecular Weight Heparin, Enoxaparin, Warfarin, Echocardiograms
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startMar 2000
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Rhone-Poulenc Rorer
- Investigators
- Cindy L Grines, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321009
- Sponsor's protocol ID
- IND 59673
- Status last verified
- May 2006
- First submitted
- 1 May 2006
- Last updated
- 3 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00321009
- Acronym / sponsor ID
- IND 59673
- Keywords
- Myocardial Infarction, Left Ventricular Mural Thrombus, Low Molecular Weight Heparin, Enoxaparin, Warfarin, Echocardiograms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Rhone-Poulenc Rorer
- Study start
- Mar 2000
- Study completion
- Apr 2004
- First posted
- 3 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 80
- Anterior myocardial infarction with:
- Ejection fraction <=40% or anterior dyskinesis or documented LV Thrombus
- MI onset < 7 days from randomization
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin | Drug | – |
Primary outcome
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.
2 secondary outcomes
What are the associated costs and length of hospital stay after randomized to
enoxaparin vs. warfarin?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L Grines, MD principal investigator
Corewell Health East
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin in people with Coronary Artery Disease and Acute Myocardial Infarction, run by Corewell Health East at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What is the incidence of LV mural thrombus with administration of enoxaparin vs.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2006.