NCT02347111 Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation
| NCT ID | NCT02347111 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Illinois at Chicago |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2020-12-31 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 162 participants in total. It began in 2020-12-31 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this pilot and feasibility study, the investigators will enroll patients with frequent symptomatic episodes of atrial fibrillation (AF) in a cross-over study testing two different classes of anti arrhythmic drugs (AADs). This pilot and feasibility study will provide preliminary data for a larger study in which the investigators will test the hypothesis that a common AF genetic risk allele modulates response to different AADs.
Eligibility Criteria
Inclusion Criteria: * ≥ 18 years of age * History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF * ECG that was recorded within 1 month of randomization showing AF * Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD * Able to give informed consent Exclusion Criteria: * Permanent AF or isolated atrial flutter * Cardiac or thoracic surgery within the previous 6 months * Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital) * Medical condition that is likely to be fatal in less than one year * A history of prior AF ablation * Have already been tried on 2 or more AADs in the past for AF * Creatinine clearance \<40 ml/min * Left ventricular ejection fraction \< 50% * Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI * Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc\>480 ms in females and \>460 ms in males at baseline * A reversible cause of AF (e.g., hyperthyroidism) * Females who are pregnant or nursing * History of severe AV node dysfunction unless an electronic pacemaker is present * First- or second-degree relative has already participated in the study * Unable to adhere to study procedures that are strictly for research purposes
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02347111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02347111 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02347111 currently recruiting?
Yes, NCT02347111 is actively recruiting participants. Contact the research team at darbar@uic.edu for enrollment information.
Where is the NCT02347111 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States, Chicago, United States, Oak Lawn, United States.
Who is sponsoring the NCT02347111 clinical trial?
NCT02347111 is sponsored by University of Illinois at Chicago. The trial plans to enroll 162 participants.
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