Atrial FibrillationNCT01607359
Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Corewell Health East at 1 site in United States.
Trial summary
Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 20 Apr 2017
- Phase
- Observational
- 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
Study population: All patients undergoing catheter ablation for atrial fibrillation
Who may be able to join
- All patients undergoing catheter ablation for atrial fibrillation
Who cannot join
- none (retrospective trial)
Trial locations and contacts
1 site in 1 country.
About this study
Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.
Read the detailed description
- Data from patients collected from 4 US and 1 Canadian medical center
- Retrospective record review of all patients that had undergone catheter ablation of atrial fibrillation during the time period beginning with the initiation of dabigatran therapy for stroke prophylaxis at each center and ending in November 2011.
- Dabigatran study group comprised of all patients that received dabigatran for stroke prophylaxis during the study time period.
- Warfarin comparison group to be selected from all patients that received warfarin for stroke prophylaxis during the identical study time period.
- Warfarin patients will be numbered sequentially
- A subgroup of warfarin patients identical in number to the dabigatran patients at each center will be selected using random number generator.
Patient data sets will be de-identified and compiled
- Master data set to be stored in Excel file
- Statistics to be performed with SAS (Cary, NC)
- Continuous data to be expressed as means ± S.D., compared with unpaired t-tests
- Categorical data will be compared with Fisher's exact test or Chi-square
- Complications including any thromboembolic events or any bleeding events will be recorded and the prevalence compared.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, dabigatran, warfarin, oral anticoagulation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dabigatran group | All patients receiving dabigatran as periprocedural anticoagulation during the study time period | |
| warfarin group | A randomly selected group of patients treated with warfarin during the study time period matching the number of dabigatran treated patients in the same time period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical stroke, TIA or systemic embolic complication
Thromboembolic complication recorded in clinical records.
Measured: 30 days before or after catheter ablation
Bleeding complication
Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.
Measured: 30 days before or after catheter ablation
Secondary outcomes (1)
Any significant complication
Any significant complication that is related to the catheter ablation procedure or to the anticoagulation regimen
Measured: 30 days before or after catheter ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completion20 Apr 2017
Why it stopped: Withdrawn: It was decided not to proceed with the study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Johns Hopkins University, London Health Sciences Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607359
- Sponsor's protocol ID
- 2007088
- Status last verified
- Dec 2016
- First submitted
- 24 May 2012
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01607359
- Acronym / sponsor ID
- 2007088
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, dabigatran, warfarin, oral anticoagulation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawn: It was decided not to proceed with the study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Johns Hopkins University, London Health Sciences Centre
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 30 May 2012 (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.
Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.
Detailed description
- Data from patients collected from 4 US and 1 Canadian medical center
- Retrospective record review of all patients that had undergone catheter ablation of atrial fibrillation during the time period beginning with the initiation of dabigatran therapy for stroke prophylaxis at each center and ending in November 2011.
- Dabigatran study group comprised of all patients that received dabigatran for stroke prophylaxis during the study time period.
- Warfarin comparison group to be selected from all patients that received warfarin for stroke prophylaxis during the identical study time period.
- Warfarin patients will be numbered sequentially
- A subgroup of warfarin patients identical in number to the dabigatran patients at each center will be selected using random number generator.
Patient data sets will be de-identified and compiled
- Master data set to be stored in Excel file
- Statistics to be performed with SAS (Cary, NC)
- Continuous data to be expressed as means ± S.D., compared with unpaired t-tests
- Categorical data will be compared with Fisher's exact test or Chi-square
- Complications including any thromboembolic events or any bleeding events will be recorded and the prevalence compared.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dabigatran group | – | –All patients receiving dabigatran as periprocedural anticoagulation during the study time period |
| warfarin group | – | –A randomly selected group of patients treated with warfarin during the study time period matching the number of dabigatran treated patients in the same time period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing catheter ablation for atrial fibrillation
Key inclusion criteria (1 listed)
- All patients undergoing catheter ablation for atrial fibrillation
Key exclusion criteria (1 listed)
- none (retrospective trial)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical stroke, TIA or systemic embolic complication
Time frame: 30 days before or after catheter ablation
Thromboembolic complication recorded in clinical records.
Bleeding complication
Time frame: 30 days before or after catheter ablation
Any bleeding causing additional intervention, hospitalization or pain and suffering including pericardial tamponade, large hematoma or other bleeding.
1 secondary outcome
Any significant complication
Time frame: 30 days before or after catheter ablation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Corewell Health East 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 11 May 2023. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical stroke, TIA or systemic embolic complication (time frame: 30 days before or after catheter ablation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.