Back to resultsABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study (ABC-AF)
Primary Purpose
Atrial Fibrillation
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ABC score guided therapy
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility 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 anticoagulant, according to the SmPC (in Sweden FASS)
- Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
- 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
- Concomitant dual antiplatelet treatment
- Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
- 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
Sites / Locations
- Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ABC score guided therapy
Standard care
Arm Description
Individual treatment recommendations based on the ABC-scores for stroke and bleeding.
Management according to local practice, national and international guidelines.
Outcomes
Primary Outcome Measures
Composite of Stroke or Death
Secondary Outcome Measures
Major Bleeding
Stroke
Death
Myocardial Infarction
Heart Failure
Health Economics
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.
Full Information
NCT ID
NCT03753490
First Posted
November 8, 2018
Last Updated
June 20, 2023
Sponsor
Uppsala University
Collaborators
Swedish Foundation for Strategic Research, Swedish Heart Lung Foundation, Roche Diagnostics, The Swedish Research Council
1. Study Identification
Unique Protocol Identification Number
NCT03753490
Brief Title
ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study
Acronym
ABC-AF
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 25, 2018 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Swedish Foundation for Strategic Research, Swedish Heart Lung Foundation, Roche Diagnostics, The Swedish Research Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3933 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ABC score guided therapy
Arm Type
Other
Arm Description
Individual treatment recommendations based on the ABC-scores for stroke and bleeding.
Arm Title
Standard care
Arm Type
Other
Arm Description
Management according to local practice, national and international guidelines.
Intervention Type
Other
Intervention Name(s)
ABC score guided therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
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 Measure Information:
Title
Composite of Stroke or Death
Time Frame
From the date of enrolment through study completion, minimum follow-up 2 years.
Secondary Outcome Measure Information:
Title
Major Bleeding
Time Frame
From the date of enrolment through study completion, minimum follow-up 2 years.
Title
Stroke
Time Frame
From the date of enrolment through study completion, minimum follow-up 2 years.
Title
Death
Time Frame
From the date of enrolment through study completion, minimum follow-up 2 years.
Title
Myocardial Infarction
Time Frame
From the date of enrolment through study completion, minimum follow-up 2 years.
Title
Heart Failure
Time Frame
From the date of enrolment through study completion, minimum follow-up 2 years.
Title
Health Economics
Description
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.
Time Frame
From the date of enrolment through study completion, minimum follow-up 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 anticoagulant, according to the SmPC (in Sweden FASS)
Indication for oral anticoagulant treatment beyond atrial fibrillation, e.g. venous thromboembolism and/or mechanical heart valve prosthesis
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
Concomitant dual antiplatelet treatment
Acute coronary syndrome (myocardial infarction or unstable angina) within the last 30 days
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas Oldgren, MD, PhD
Organizational Affiliation
Uppsala Clinical Reseach Center, UCR
Official's Role
Study Director
Facility Information:
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study
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