Sub-Clinical Atrial Fibrillation Biomarker Study

NCT02840201 | Completed

• 1 other identifier: 20150023
• Study Type: observational
• Target: 321
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Subclinical Atrial Fibrillation

Keywords

biomarkers

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (1)

• The time related onset of complications

  3 years

Other Outcomes (1)

• Comparison of time related onset of complications between those receiving aspirin versus apixaban.

  3 years

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Canadian patients participating in the ARTESiA study will be recruited for this sub-study.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Genome Canada: collaborator
• Pfizer: collaborator
• Medtronic: collaborator
• Population Health Research Institute: collaborator
• Bristol-Myers Squibb: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for biomarker evaluation.

Study Officials

• Peter Liu, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 21, 2016
• Study Start: June 26, 2017
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)