Atrial FibrillationNCT02222090
Therapy With New Oral Anticoagulants
An observational study of Atrial Fibrillation and Non-valvular Atrial Fibrillation, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of the present registry is to characterize and follow patients prospectively and retrospectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Non-valvular Atrial Fibrillation
- How many people
- 1,500 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Jul 2016
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients prospectively and retropectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population
Who may be able to join
- Patients with renal dysfunction (eGFR <60 ml\min\BSA) who have an indication for treatment with an novel oral anticoagulant agent or VKA
- Patients prescribed apixaban or warfarin at the enrollment center (patients enrolled in a 2:1 ratio)
Who cannot join
- Valvular AF or presence prosthetic valve
- Dialysis patients
- Contraindications NOACs
- Hepatic dysfunction
- Cognitive impairment
- Clinical necessity to continue administration of potent inhibitors of both CYP3A4 and P-gp - including azole- antimycotics (e.g. ketoconazole, itraconazole) and HIV protease inhibitors (e.g. ritonavir)
Trial locations and contacts
1 site in 1 country.
Ilan Goldenberg, Prof contact
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan, 5262179
Ilan Goldenberg, MD, 972-5302848, ilan.goldenberg@sheba.health.gov.il
Ilan Goldenberg, Prof
About this study
Official title: Therapy With New Oral Anticoagulants in Patients With Atrial Fibrillation and Renal Impairment
The aim of the present registry is to characterize and follow patients prospectively and retrospectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population.
Read the detailed description
Current guidelines for the management of patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF .Renal dysfunction has been shown to be an independent predictor of stroke or systemic emboli, but the risk of bleeding with conventional warfarin therapy is also significantly increased.Prevalence of renal dysfunction in patients with atrial fibrillation is high, with approximately 60% of patients having an estimated glomerular filtration rate (eGFR) of ≤ 60 ml/min/BSA [6].NOACs undergoing significant renal secretion such as dabigatran are not recommended for patients with severe renal impairment, and dose adjustment are indicated for patients with milder degrees of renal dysfunction.However, real-world information regarding the usage and outcomes associated with NOAC therapy in patients with renal dysfunction are limited. The investigators plan to prospectively and retrospectively collect data regarding the clinical settings, characteristics, and outcomes of patients with renal dysfunction who have been prescribed apixaban in Israel, using a multicenter secure web-based registry.
- Keywords
- patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF
- 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 |
|---|---|---|
| patients who have been prescribed warfarin | Not described | |
| patients who have been prescribed apixaba | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcomes
To evaluate the clinical characteristics, treatment indications, and risks of stroke and bleeding in non-valvular atrial fibrillation patients prescribed apixaban or warfarin.
Measured: within 12 month from enrollment
Secondary outcomes (1)
one-year outcomes
Establish the one-year outcomes of this patient population
Measured: within 12 month from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015 (estimated)
- Study completionJul 2016 (estimated)
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.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ilan Goldenberg, Prof, Study director, Sheba Medical CenterAlon Barsheshet, MD, Principal investigator, beilinson Medical CenterAvishay Elias, MD, Principal investigator, beilinson Medical CenterShmuel Fuchs, Prof, Principal investigator, beilinson Medical centerKIRILL BUTURLIN, MD, Principal investigator, Meir Medical CenterMoshe Swissa, MD, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222090
- Sponsor's protocol ID
- SHEBA-14-1181-IG-CTIL
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy With New Oral Anticoagulants in Patients With Atrial Fibrillation and Renal Impairment
- ClinicalTrials.gov ID
- NCT02222090
- Acronym / sponsor ID
- SHEBA-14-1181-IG-CTIL
- Keywords
- patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 21 Aug 2014 (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.
The aim of the present registry is to characterize and follow patients prospectively and retrospectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population.
Detailed description
Current guidelines for the management of patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF .Renal dysfunction has been shown to be an independent predictor of stroke or systemic emboli, but the risk of bleeding with conventional warfarin therapy is also significantly increased.Prevalence of renal dysfunction in patients with atrial fibrillation is high, with approximately 60% of patients having an estimated glomerular filtration rate (eGFR) of ≤ 60 ml/min/BSA [6].NOACs undergoing significant renal secretion such as dabigatran are not recommended for patients with severe renal impairment, and dose adjustment are indicated for patients with milder degrees of renal dysfunction.However, real-world information regarding the usage and outcomes associated with NOAC therapy in patients with renal dysfunction are limited. The investigators plan to prospectively and retrospectively collect data regarding the clinical settings, characteristics, and outcomes of patients with renal dysfunction who have been prescribed apixaban in Israel, using a multicenter secure web-based registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who have been prescribed warfarin | – | – |
| patients who have been prescribed apixaba | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients prospectively and retropectively with renal impairment who have been prescribed apixaban for the prevention of stroke in atrial fibrillation, with a comparison to the characteristics and outcomes associated with warfarin therapy in this population
Key inclusion criteria (2 listed)
- Patients with renal dysfunction (eGFR <60 ml\min\BSA) who have an indication for treatment with an novel oral anticoagulant agent or VKA
- Patients prescribed apixaban or warfarin at the enrollment center (patients enrolled in a 2:1 ratio)
Key exclusion criteria (6 listed)
- Valvular AF or presence prosthetic valve
- Dialysis patients
- Contraindications NOACs
- Hepatic dysfunction
- Cognitive impairment
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 Outcomes
Time frame: within 12 month from enrollment
To evaluate the clinical characteristics, treatment indications, and risks of stroke and bleeding in non-valvular atrial fibrillation patients prescribed apixaban or warfarin.
1 secondary outcome
one-year outcomes
Time frame: within 12 month from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
Related trials for Atrial Fibrillation
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, 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.
Ilan Goldenberg, Prof contact
Ilan Goldenberg, Prof study director
Sheba Medical Center
Alon Barsheshet, MD principal investigator
beilinson Medical Center
Avishay Elias, MD principal investigator
beilinson Medical Center
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 and Non-valvular Atrial Fibrillation, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Aug 2014. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Goldenberg, Prof (Ilan.Goldenberg@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcomes (time frame: within 12 month from enrollment). 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 21 Aug 2014.