ClinicalTrials.gov
ClinicalTrials.gov Menu

ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study (ABC-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03753490
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborators:
Swedish Foundation for Strategic Research
Swedish Heart Lung Foundation
Roche Diagnostics
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
The primary study objective is to evaluate if personalized treatment by decision support, based on the biomarker-based risk prediction (ABC-scores) guided strategy, reduces the occurrence of the composite outcome of stroke or death in patients with atrial fibrillation. Approximately 6500 patients will be randomized 1:1 to ABC risk score guided therapy or standard care.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: ABC score guided therapy Other: Standard care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ABC-Risk Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - a Multicenter, Registry-based, Randomized Controlled Parallel-group Open-label Study
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ABC score guided therapy
Individual treatment recommendations based on the ABC-scores for stroke and bleeding.
Other: ABC score guided therapy
In the ABC arm, individual treatment recommendations based on the ABC-scores for stroke and bleeding including non-vitamin K oral anticoagulant or no anticoagulant treatment, and other drugs and interventions, to improve stroke free survival.

Standard care
Management according to local practice, national and international guidelines.
Other: Standard care
In the standard care arm, management according to local practice, national and international guidelines, including the potential use of traditional clinical risk scores for stroke and/or bleeding, anticoagulant treatment and other treatments and interventions.




Primary Outcome Measures :
  1. Composite of Stroke or Death [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]

Secondary Outcome Measures :
  1. Major Bleeding [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
  2. Stroke [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
  3. Death [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
  4. Myocardial Infarction [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
  5. Heart Failure [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
  6. Health Economics [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
    Mean differences in health care cost, and 2-year quality-adjusted survival based on EuroQol-5D-5L between the treatment groups, combined into an incremental cost-effectiveness ratio.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diagnosis of atrial fibrillation, including newly diagnosed, with or without current oral anticoagulant treatment.
  • Signed informed consent

Exclusion Criteria:

  • Contraindication for any oral anticoagulants, according to the SmPC.
  • Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
  • Currently on treatment with a NOAC and not eligible/candidate for change of NOAC drug, e.g. drug-drug interactions
  • Concomitant dual antiplatelet treatment
  • Participation in anti-thrombotic pharmaceutical trial
  • Planned for AF ablation or AF surgery
  • Haemoglobin < 90 g/L
  • Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753490


Contacts
Contact: Lina Gifting +46186171108 abcafstudy@ucr.uu.se
Contact: Ziad Hijazi, MD, PhD +46186119500 ziad.hijazi@ucr.uu.se

Locations
Sweden
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Ziad Hijazi, MD, PhD         
Sponsors and Collaborators
Uppsala University
Swedish Foundation for Strategic Research
Swedish Heart Lung Foundation
Roche Diagnostics
Investigators
Study Director: Jonas Oldgren, MD, PhD Uppsala Clinical Reseach Center, UCR

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03753490     History of Changes
Other Study ID Numbers: 1011455
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes