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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 01, 2014