Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00289042
First received: February 8, 2006
Last updated: January 30, 2007
Last verified: May 2005
  Purpose

SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH, enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm.

HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis) compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion. The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious approach to cardioversion of atrial fibrillation compared to UFH with TEE.


Condition Intervention Phase
Atrial Fibrillation
Drug: Enoxaparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Enoxaparin Compared to Unfractionated Heparin for Short Term Antithrombotic Therapy in Atrial Fibrillation Patients Undergoing TEE Guided Cardioversion: Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) II Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • ischemic stroke
  • transient ischemic attack
  • peripheral embolism
  • major or minor bleeding
  • death
  • length of stay (LOS)
  • return to normal sinus rhythm (NSR)

Secondary Outcome Measures:
  • quality of life
  • cost-effectiveness

Estimated Enrollment: 200
Study Start Date: December 1999
Estimated Study Completion Date: November 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic or paroxysmal atrial fibrillation of > 2 days duration who are candidates for early chemical or electrical cardioversion
  • Patients with atrial flutter with a documented history (electrocardiography) of atrial fibrillation
  • Males and females 18 years of age or older
  • Patients have available results of routine clinical labs for standard clinical chemistry and complete blood count within the previous 14 days

Exclusion Criteria:

  • An INR > 1.4 in patients who have received warfarin prior to enrollment.
  • Use of IV heparin for more than 72 hours immediately prior to randomization.
  • Patients with contraindications to TEE, such as dysphagia, or esophageal strictures.
  • Patients who will need anticoagulation discontinued because of elective intervening procedure, such as cardiac catheterization or surgery.
  • Patients with contraindications to warfarin or heparin
  • Patients who require concomitant therapy during the study period with any drug known to affect coagulation or platelet function (i.e. ASA, NSAID, antiplatelet drugs)
  • Women of childbearing potential, unless pregnancy can be excluded by medical history incompatible with pregnancy or by serum or urine beta HCG levels.
  • Patients who are hemodynamically unstable and thus may require immediate cardioversion.
  • Weight less than 40 kg (88 pounds) or more than 125 kg (275 pounds)
  • History of gastrointestinal bleeding disorder and/or endoscopically verified ulcer disease within the last year
  • History of intracranial or retinal bleeding, or other known disorders with an increased risk of bleeding
  • Ischemic stroke in the previous three months
  • Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 100 mm Hg)
  • Malignancy currently under active treatment, including melanoma
  • Patients with renal insufficiency (creatinine > 2.0 mg/dL) or are renal transplant subjects
  • Patients with anemia (Hgb less than 10 gm/dL)
  • Patients with thrombocytopenia (platelet count less than 100 x 10^9/L)
  • Positive fecal hemoglobin test
  • Life expectancy of less than 6 months
  • History of drug and/or alcohol abuse within the last two years
  • Patients unable or unwilling to give informed consent
  • Patients unable or unwilling to return for follow-up
  • Prisoners or wards of the state
  • Patients with psychological problems that may decrease compliance with the protocol
  • Not willing to complete the Quality of Life Questionnaires x 3
  • Participating in another clinical trial and/or taking an investigational medication in the past 30 days
  • Patient language, learning skills, or home environment unconducive to self-management
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289042

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Sanofi
Investigators
Principal Investigator: Allan L. Klein, MD The Cleveland Clinic
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00289042     History of Changes
Other Study ID Numbers: IRB 2879
Study First Received: February 8, 2006
Last Updated: January 30, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
atrial fibrillation
atrial thrombus
cardioversion
enoxaparin
low molecular weight heparin
transesophageal echocardiography

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heparin
Heparin, Low-Molecular-Weight
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 April 14, 2014