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

Study Description

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 Design

• 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: November 25, 2018
• Estimated Primary Completion Date: October 31, 2024
• Estimated Study Completion Date: October 31, 2024

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Christina Björklund; +46186173349; 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

The Swedish Research Council

Investigators

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

More Information

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT03753490
• Other Study ID Numbers: 1011455
• First Posted: November 27, 2018
• Last Update Posted: May 9, 2022
• Last Verified: May 2022

• 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