Subclinical Atrial FibrillationSCAF-bNCT02840201
Sub-Clinical Atrial Fibrillation Biomarker Study
An observational study of Subclinical Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
This is a sub-study of the ARTESiA study registered as NCT01938248. This study is designed to validate biomarkers in subclinical atrial fibrillation and to determine if the prospective biomarker will be informative of the potential efficacy of treatment. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Subclinical Atrial Fibrillation
- How many people
- 321 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jun 2017to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Canadian patients participating in the ARTESiA study will be recruited for this sub-study.
Who may be able to join
- Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor
- At least one episode of device-detected SCAF ≥ 6 minutes in duration but no single episode > 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average > 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration
- Age ≥ 55 years
- Risk Factor(s) for Stroke:
- Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors
- Other risk factors are:
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- Hypertension
- CHF
- Diabetes
- Vascular disease (i.e. CAD, PAD or Aortic Plaque)
- Female
- Must be from a participating Canadian recruitment centre
- Consent to participate in the ARTESiA parent study
Who cannot join
- Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting ≥ 6 minutes, with or without clinical symptoms
- Mechanical valve prosthesis, recent (within past 6 months) deep vein thrombosis or pulmonary embolism or other condition requiring treatment with an anticoagulant
- Allergy to aspirin or apixaban
- Severe renal insufficiency (serum creatinine > 2.5 mg/dL [221 μmol/L] or a calculated creatinine clearance < 25 ml/min)
- Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, clinically significant thrombocytopenia or anemia, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias)
- Moderate to severe hepatic impairment
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- Ongoing need for combination therapy with aspirin and clopidogrel (or other combination of two platelet inhibitors)
- Meets criteria for requiring lower dose of apixaban AND also has ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
- Ongoing need for strong inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
- Received an investigational drug in the past 30 days
- Participants considered by the investigator to be unsuitable for the study for any of the following reasons:
- Not agreeable for treatment with either aspirin or apixaban or anticipated to have poor compliance on study drug treatment
- Unwilling to attend study follow-up visits
- Life expectancy less than 2 years due to concomitant disease
- Women who are pregnant, breast-feeding or of child-bearing potential without an acceptable form of contraception in place (sterilization, abstinence or other method with less than 1% failure rate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sub-Clinical Atrial Fibrillation Biomarker (SCAF-b): A Sub-study of Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA)
This is a sub-study of the ARTESiA study registered as NCT01938248. This study is designed to validate biomarkers in subclinical atrial fibrillation and to determine if the prospective biomarker will be informative of the potential efficacy of treatment.
Read the detailed description
Atrial fibrillation (AF) is the most common cardiac rhythm disorder worldwide, and is gaining in prevalence. Currently, the treatment for atrial fibrillation is concentrated on patients with existing atrial fibrillation, and the reduction in risks of complications of stroke with anticoagulation. Furthermore, mechanical interventions such as atrial ablation procedures are fraught with inconsistent results. The availability of serum based biomarkers that can predict the early onset of atrial fibrillation, and also the ability to prognosticate risk, may help in the identification of patients at risk for AF complications early. This would also allow the identification of the patient population most suitable for the evaluation of possible future intervention strategies to prevent the onset of atrial fibrillation, and alter its natural history and complications.
Currently the best biomarkers in predicting atrial fibrillation risk are in fact markers for heart failure - NTproBNP and high sensitivity troponin. These markers are independent from CHA2DS2-VASc score. While this is very helpful, these markers will not be able to distinguish these 2 conditions because heart failure and atrial fibrillation often co-exist. The investigator's Cardiovascular Biomarker Discovery and Translation team has been using deep proteomic analysis of both human tissues and reprogrammed human stem cells to identify novel candidate biomarkers. This has been very successfully applied to diastolic heart failure, and there are now several new markers for this condition that have been validated across 3 populations. The investigators have several potential candidates for atrial fibrillation, but validation in the appropriate cohort, particularly those at the earliest risks of atrial fibrillation, will be most important.
The ARTESiA study is an ideal study setting to perform the biomarker validation, as the parent trial will recruit patients with silent atrial fibrillation detected only by dual-chamber pacemakers, defibrillators or insertable cardiac monitors. This would constitute a potentially earlier stage atrial fibrillation patient cohort, with known subsequent risks in a prospective fashion. The prospective evaluation of approved medications of aspirin and apixaban will also be helpful to determine if the prospective biomarker will be informative of the potential efficacy of treatment, or be unchanged by the treatment modalities.
- Conditions
- Subclinical Atrial Fibrillation
- Keywords
- biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
The burden of silent atrial fibrillation as recorded on implanted devices in patients
as predicted by levels of proBNP, hsTnT and additional novel marker candidates
Measured: 3 years
Secondary outcomes (1)
The time related onset of complications
complications include embolic stroke, cerebral hemorrhage, myocardial infarction, heart failure and cardiac death, as predicted by both novel and known biomarkers outlined above.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start26 Jun 2017
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute, Genome Canada, Bristol-Myers Squibb, Pfizer, Medtronic, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Peter Liu, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840201
- Sponsor's protocol ID
- 20150023
- Acronym
- SCAF-b
- Status last verified
- Jan 2026
- First submitted
- 11 Jul 2016
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-Clinical Atrial Fibrillation Biomarker (SCAF-b): A Sub-study of Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA)
- ClinicalTrials.gov ID
- NCT02840201
- Acronym / sponsor ID
- SCAF-b / 20150023
- Conditions
- Subclinical Atrial Fibrillation
- Keywords
- biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Population Health Research Institute, Genome Canada, Bristol-Myers Squibb, Pfizer, Medtronic, Canadian Institutes of Health Research (CIHR)
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a sub-study of the ARTESiA study registered as NCT01938248. This study is designed to validate biomarkers in subclinical atrial fibrillation and to determine if the prospective biomarker will be informative of the potential efficacy of treatment.
Detailed description
Atrial fibrillation (AF) is the most common cardiac rhythm disorder worldwide, and is gaining in prevalence. Currently, the treatment for atrial fibrillation is concentrated on patients with existing atrial fibrillation, and the reduction in risks of complications of stroke with anticoagulation. Furthermore, mechanical interventions such as atrial ablation procedures are fraught with inconsistent results. The availability of serum based biomarkers that can predict the early onset of atrial fibrillation, and also the ability to prognosticate risk, may help in the identification of patients at risk for AF complications early. This would also allow the identification of the patient population most suitable for the evaluation of possible future intervention strategies to prevent the onset of atrial fibrillation, and alter its natural history and complications.
Currently the best biomarkers in predicting atrial fibrillation risk are in fact markers for heart failure - NTproBNP and high sensitivity troponin. These markers are independent from CHA2DS2-VASc score. While this is very helpful, these markers will not be able to distinguish these 2 conditions because heart failure and atrial fibrillation often co-exist. The investigator's Cardiovascular Biomarker Discovery and Translation team has been using deep proteomic analysis of both human tissues and reprogrammed human stem cells to identify novel candidate biomarkers. This has been very successfully applied to diastolic heart failure, and there are now several new markers for this condition that have been validated across 3 populations. The investigators have several potential candidates for atrial fibrillation, but validation in the appropriate cohort, particularly those at the earliest risks of atrial fibrillation, will be most important.
The ARTESiA study is an ideal study setting to perform the biomarker validation, as the parent trial will recruit patients with silent atrial fibrillation detected only by dual-chamber pacemakers, defibrillators or insertable cardiac monitors. This would constitute a potentially earlier stage atrial fibrillation patient cohort, with known subsequent risks in a prospective fashion. The prospective evaluation of approved medications of aspirin and apixaban will also be helpful to determine if the prospective biomarker will be informative of the potential efficacy of treatment, or be unchanged by the treatment modalities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canadian patients participating in the ARTESiA study will be recruited for this sub-study.
Key inclusion criteria (13 listed)
- Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor
- At least one episode of device-detected SCAF ≥ 6 minutes in duration but no single episode > 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average > 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration
- Age ≥ 55 years
- Risk Factor(s) for Stroke:
- Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors
Key exclusion criteria (15 listed)
- Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting ≥ 6 minutes, with or without clinical symptoms
- Mechanical valve prosthesis, recent (within past 6 months) deep vein thrombosis or pulmonary embolism or other condition requiring treatment with an anticoagulant
- Allergy to aspirin or apixaban
- Severe renal insufficiency (serum creatinine > 2.5 mg/dL [221 μmol/L] or a calculated creatinine clearance < 25 ml/min)
- Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, clinically significant thrombocytopenia or anemia, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The burden of silent atrial fibrillation as recorded on implanted devices in patients
Time frame: 3 years
as predicted by levels of proBNP, hsTnT and additional novel marker candidates
1 secondary outcome
The time related onset of complications
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Liu, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Atrial Fibrillation, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The burden of silent atrial fibrillation as recorded on implanted devices in patients (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.