Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00289042

Collaborator

Sanofi (Industry)

200

Enrollment

Location

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Enoxaparin	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

None (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

Study Start Date :

Dec 1, 1999

Study Completion Date :

Nov 1, 2004

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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