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Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, atrial thrombus, cardioversion, enoxaparin, low molecular weight heparin, transesophageal echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cleveland Clinic

Outcomes

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

Full Information

First Posted
February 8, 2006
Last Updated
January 30, 2007
Sponsor
The Cleveland Clinic
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00289042
Brief Title
Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)
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 Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Cleveland Clinic
Collaborators
Sanofi

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, atrial thrombus, cardioversion, enoxaparin, low molecular weight heparin, transesophageal echocardiography

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Primary Outcome Measure Information:
Title
ischemic stroke
Title
transient ischemic attack
Title
peripheral embolism
Title
major or minor bleeding
Title
death
Title
length of stay (LOS)
Title
return to normal sinus rhythm (NSR)
Secondary Outcome Measure Information:
Title
quality of life
Title
cost-effectiveness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan L. Klein, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11346805
Citation
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. doi: 10.1056/NEJM200105103441901.
Results Reference
background
PubMed Identifier
11241016
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. doi: 10.1067/mje.2001.109505.
Results Reference
background
PubMed Identifier
10827367
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. doi: 10.1067/mhj.2000.106628.
Results Reference
background
PubMed Identifier
18657673
Citation
Elliott DJ, Zhao L, Jasper SE, Lieber EA, Klein AL, Weintraub WS. Health status outcomes after cardioversion for atrial fibrillation: results from the Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) II Trial. Am Heart J. 2008 Aug;156(2):374.e1-6. doi: 10.1016/j.ahj.2008.05.008.
Results Reference
derived

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Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)

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