Blood markers may reveal hidden stroke risk in heart patients
NCT ID NCT02840201
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at 321 people with pacemakers or heart monitors who had short, symptomless episodes of atrial fibrillation (silent AF). Researchers measured certain proteins in the blood to see if they could predict who might later have a stroke or other heart problems. The goal is to better identify who needs blood-thinning medication.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help doctors identify which patients with silent atrial fibrillation are at highest risk for stroke and might benefit from blood thinners.
- What could go wrong
- This is a small, completed sub-study analyzing existing data, not a treatment trial. The findings may not change current practice without larger confirmatory studies.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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321 people
The number who actually took part.
- Started
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Jun 2017
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Canadian patients participating in the ARTESiA study will be recruited for this sub-study.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: * 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 Exclusion Criteria: * 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 * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
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