Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation (NCT02347111) is a Phase 4 interventional studying Atrial Fibrillation, sponsored by University of Illinois at Chicago. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 162 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Atrial Fibrillation subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - ≥ 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Flecainide

flecainide up to 150mg twice daily for the control of atrial fibrillation

DRUG

Sotalol

sotalol up to 120mg twice daily for the control of atrial fibrillation

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jesse Brown VA Medical Center

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT02347111), the sponsor (University of Illinois at Chicago), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT02347111 clinical trial studying?

Who can participate in NCT02347111?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT02347111?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT02347111. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT02347111. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.