Therapy With New Oral Anticoagulants

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02222090
First received: August 4, 2014
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition
Atrial Fibrillation
Non-valvular Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Therapy With New Oral Anticoagulants in Patients With Atrial Fibrillation and Renal Impairment

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Clinical Outcomes [ Time Frame: within 12 month from enrollment ] [ Designated as safety issue: No ]
    To evaluate the clinical characteristics, treatment indications, and risks of stroke and bleeding in non-valvular atrial fibrillation patients prescribed apixaban or warfarin.


Secondary Outcome Measures:
  • one-year outcomes [ Time Frame: within 12 month from enrollment ] [ Designated as safety issue: No ]
    Establish the one-year outcomes of this patient population


Estimated Enrollment: 1500
Study Start Date: July 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients who have been prescribed warfarin
patients who have been prescribed apixaba

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02222090

Contacts
Contact: Ilan Goldenberg, Prof Ilan.Goldenberg@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 5262179
Contact: Ilan Goldenberg, MD    972-5302848    ilan.goldenberg@sheba.health.gov.il   
Principal Investigator: Ilan Goldenberg, Prof         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Ilan Goldenberg, Prof Sheba Medical Center
Principal Investigator: Alon Barsheshet, MD beilinson Medical Center
Principal Investigator: Avishay Elias, MD beilinson Medical Center
Principal Investigator: Shmuel Fuchs, Prof beilinson Medical center
Principal Investigator: KIRILL BUTURLIN, MD Meir Medical Center
Principal Investigator: Moshe Swissa, MD Kaplan Medical Center
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02222090     History of Changes
Other Study ID Numbers: SHEBA-14-1181-IG-CTIL
Study First Received: August 4, 2014
Last Updated: August 20, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
patients with atrial fibrillation (AF) recommend the use of novel oral anticoagulants (NOACs) in patients with non-valvular AF

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014