Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289042
• Other study ID #: IRB 2879
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2006
• Last updated: January 30, 2007
• Start date: December 1999
• Est. completion date: November 2004

Study information

• Verified date: May 2005
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Enoxaparin

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (3)

Klein AL, Grimm RA, Murray RD, Apperson-Hansen C, Asinger RW, Black IW, Davidoff R, Erbel R, Halperin JL, Orsinelli DA, Porter TR, Stoddard MF; Assessment of Cardioversion Using Transesophageal Echocardiography Investigators. Use of transesophageal echocardiography to guide cardioversion in patients with atrial fibrillation. N Engl J Med. 2001 May 10;344(19):1411-20. — View Citation

Murray RD, Deitcher SR, Shah A, Jasper SE, Bashir M, Grimm RA, Klein AL. Potential clinical efficacy and cost benefit of a transesophageal echocardiography-guided low-molecular-weight heparin (enoxaparin) approach to antithrombotic therapy in patients undergoing immediate cardioversion from atrial fibrillation. J Am Soc Echocardiogr. 2001 Mar;14(3):200-8. — View Citation

Murray RD, Shah A, Jasper SE, Goodman A, Deitcher SR, Katz WE, Malouf JF, Stoddard MF, Grimm RA, Klein AL; ACUTE II pilot study. Transesophageal echocardiography guided enoxaparin antithrombotic strategy for cardioversion of atrial fibrillation: the ACUTE II pilot study. Am Heart J. 2000 Jun;139(6):E1-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ischemic stroke
Primary	transient ischemic attack
Primary	peripheral embolism
Primary	major or minor bleeding
Primary	death
Primary	length of stay (LOS)
Primary	return to normal sinus rhythm (NSR)
Secondary	quality of life
Secondary	cost-effectiveness