Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)

January 30, 2007 updated by: The Cleveland Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
quality of life
cost-effectiveness

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Sanofi

Investigators

  • Principal Investigator: Allan L. Klein, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

February 8, 2006

First Submitted That Met QC Criteria

February 8, 2006

First Posted (Estimate)

February 9, 2006

Study Record Updates

Last Update Posted (Estimate)

January 31, 2007

Last Update Submitted That Met QC Criteria

January 30, 2007

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 2879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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