Status:
COMPLETED
Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Sanofi
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ther...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00289042
Start Date
December 1 1999
End Date
November 1 2004
Last Update
January 31 2007
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195