Atrial FibrillationPhase 4NCT00289042
Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)
A Phase 4 study testing Enoxaparin in people with Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Enoxaparin
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to Nov 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Enoxaparin
- Keywords
- atrial fibrillation, atrial thrombus, cardioversion, enoxaparin, low molecular weight heparin, transesophageal echocardiography
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic stroke
transient ischemic attack
peripheral embolism
major or minor bleeding
death
length of stay (LOS)
return to normal sinus rhythm (NSR)
Secondary outcomes (2)
quality of life
cost-effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startDec 1999
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Allan L. Klein, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289042
- Sponsor's protocol ID
- IRB 2879
- Status last verified
- May 2005
- First submitted
- 8 Feb 2006
- Last updated
- 31 Jan 2007
- Results posted
- No
Publications
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.
PubMed 11346805Murray 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.
PubMed 11241016Murray 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.
PubMed 10827367Elliott 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.
PubMed 18657673
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00289042
- Acronym / sponsor ID
- IRB 2879
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, atrial thrombus, cardioversion, enoxaparin, low molecular weight heparin, transesophageal echocardiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 1999
- Study completion
- Nov 2004
- First posted
- 9 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin | Drug | – |
Primary outcome
ischemic stroke
transient ischemic attack
peripheral embolism
major or minor bleeding
death
length of stay (LOS)
return to normal sinus rhythm (NSR)
2 secondary outcomes
quality of life
cost-effectiveness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2007.
- Background: PubMed 11346805Klein 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.
- Background: PubMed 11241016Murray 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.
- Background: PubMed 10827367Murray 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.
- Derived from this study: PubMed 18657673Elliott 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.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan L. Klein, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enoxaparin in people with Atrial Fibrillation, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemic stroke. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00289042, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2007.