- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00321009
LV Thrombus Pilot Study for Comparing Enoxaparin Vs. Warfarin
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Colorado
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Denver, Colorado, Forenede Stater, 80262
- University of Colorado Health Sciences Center
-
-
Michigan
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Royal Oak, Michigan, Forenede Stater, 48073
- William Beaumont Hospital
-
-
New York
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Syracuse, New York, Forenede Stater, 13203
- St Joseph's Health Center Dept. of Cardiology
-
-
North Carolina
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Greensboro, North Carolina, Forenede Stater, 27403
- LaBauer Cardiovascular Research Foundation
-
-
Pennsylvania
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Doylestown, Pennsylvania, Forenede Stater, 18901
- Doylestown Hospital
-
-
Virginia
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Virginia Beach, Virginia, Forenede Stater, 23454
- Cardiovascular Associates Ltd.
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
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.
|
Sekundære resultatmål
Resultatmål |
---|
What are the associated costs and length of hospital stay after randomized to
|
enoxaparin vs. warfarin?
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cindy L Grines, MD, William Beaumont Hospitals
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Iskæmi
- Patologiske processer
- Nekrose
- Myokardieiskæmi
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Embolisme og trombose
- Koronar sygdom
- Myokardieinfarkt
- Infarkt
- Koronararteriesygdom
- Trombose
- Molekylære mekanismer for farmakologisk virkning
- Fibrinolytiske midler
- Fibrinmodulerende midler
- Antikoagulanter
- Enoxaparin
Andre undersøgelses-id-numre
- IND 59673
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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