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

• ClinicalTrials.gov Identifier: NCT03753490
• Recruitment Status: Recruiting
• First Posted: November 27, 2018
• Last Update Posted: May 9, 2022
• Sponsor: Uppsala University
• Collaborators: Swedish Foundation for Strategic Research; Swedish Heart Lung Foundation; Roche Diagnostics; The Swedish Research Council
• Information provided by (Responsible Party): Uppsala University

Tracking Information

• First Submitted Date: November 8, 2018
• First Posted Date: November 27, 2018
• Last Update Posted Date: May 9, 2022
• Actual Study Start Date: November 25, 2018
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 21, 2018): Composite of Stroke or Death [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 21, 2018)

• Major Bleeding [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
• Stroke [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
• Death [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
• Myocardial Infarction [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
• Heart Failure [ Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years. ]
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Atrial Fibrillation

Intervention

• 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.
• 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.

Study Arms

• ABC score guided therapy
  Individual treatment recommendations based on the ABC-scores for stroke and bleeding.
  Intervention: Other: ABC score guided therapy
• Standard care
  Management according to local practice, national and international guidelines.
  Intervention: Other: Standard care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 21, 2018): 6500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 31, 2024
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

1. Contraindication for any oral anticoagulant, according to the SmPC (in Sweden FASS)
2. Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
3. Currently on treatment with a non-vitamin K antagonist oral anticoagulant (NOAC) and not eligible for change of NOAC drug e.g. drug-drug interactions
4. Concomitant dual antiplatelet treatment
5. Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
6. Participation in anti-thrombotic pharmaceutical trial
7. Planned for AF ablation or AF surgery
8. Haemoglobin <90 g/L
9. Patients who, in the opinion of the investigator, cannot or will not comply with the requirements of the protocol

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christina Björklund; +46186173349; abcafstudy@ucr.uu.se

Contact: Ziad Hijazi, MD, PhD; +46186119500; ziad.hijazi@ucr.uu.se

• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03753490
• Other Study ID Numbers: 1011455
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Uppsala University
• Original Responsible Party: Same as current
• Current Study Sponsor: Uppsala University
• Original Study Sponsor: Same as current

Collaborators

• Swedish Foundation for Strategic Research
• Swedish Heart Lung Foundation
• Roche Diagnostics
• The Swedish Research Council

Investigators

• Study Director: Jonas Oldgren, MD, PhD; Uppsala Clinical Reseach Center, UCR

• PRS Account: Uppsala University
• Verification Date: May 2022