- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03753490
ABC-Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - The ABC-AF Study (ABC-AF)
June 20, 2023 updated by: Uppsala University
ABC-Risk Scores for Reduction of Stroke and Mortality in Atrial Fibrillation - a Multicenter, Registry-based, Randomized Controlled Parallel-group Open-label Study
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
3933
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina Björklund
- Phone Number: +46186173349
- Email: abcafstudy@ucr.uu.se
Study Contact Backup
- Name: Ziad Hijazi, MD, PhD
- Phone Number: +46186119500
- Email: ziad.hijazi@ucr.uu.se
Study Locations
-
-
-
Uppsala, Sweden
- Uppsala University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ABC score guided therapy
Individual treatment recommendations based on the ABC-scores for stroke and bleeding.
|
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
Management according to local practice, national and international guidelines.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of Stroke or Death
Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years.
|
From the date of enrolment through study completion, minimum follow-up 2 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major Bleeding
Time Frame: From the date of enrolment through study completion, minimum follow-up 2 years.
|
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.
|
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.
|
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.
|
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.
|
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.
|
From the date of enrolment through study completion, minimum follow-up 2 years.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Jonas Oldgren, MD, PhD, Uppsala Clinical Reseach Center, UCR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 25, 2018
Primary Completion (Estimated)
May 31, 2025
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
November 8, 2018
First Submitted That Met QC Criteria
November 21, 2018
First Posted (Actual)
November 27, 2018
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1011455
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
Ablacon, Inc.RecruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Barts & The London NHS TrustAtriCure, Inc.Not yet recruitingAtrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial Arrhythmia | Atrium; FibrillationUnited Kingdom
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
-
Vivek ReddyEnrolling by invitationAtrial Fibrillation and Flutter | Atrial Flutter Typical | Atrial Fibrillation, Paroxysmal or PersistentUnited States
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingAtrial Arrhythmia | Atrial Fibrillation and Flutter | Atrial Fibrillation RecurrentSpain
-
St. George's Hospital, LondonRecruitingAtrial Fibrillation | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Atrial ArrhythmiaUnited Kingdom
-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on ABC score guided therapy
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Completed
-
China National Center for Cardiovascular DiseasesCompleted
-
University of DelawareNational Institute of Mental Health (NIMH)CompletedAttachment DisordersUnited States
-
Rigshospitalet, DenmarkUniversity of Copenhagen; Herlev HospitalEnrolling by invitationCardiovascular Diseases | Coronary Atherosclerosis and Other Heart DiseaseDenmark
-
University of DelawareCompleted
-
Englewood Hospital and Medical CenterTerminated
-
VA Office of Research and DevelopmentRecruiting
-
Giselle ShollerDell, Inc.Active, not recruitingMedulloblastoma | Neuroblastoma | Brain Tumors | Rare TumorsUnited States
-
Jonsson Comprehensive Cancer CenterActive, not recruitingProstate AdenocarcinomaUnited States
-
University of Michigan Rogel Cancer CenterCompleted