Last Update: Nov 21, 2025
A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation
ClinicalTrials.gov Identifier:
Novartis Reference Number:CPKN605A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillaiton A screening period of up to 90 days will be conducted to determine participants' eligibility. Once eligibility is confirmed, participants will be randomly assigned to receive either PKN605 or placebo. The treatment phase will last for 24 weeks, during which participants will visit the clinic approximately once a month. During the study, participants' atrial fibrillation will be monitored using various ECG devices. Approximately one month after the end of the treatment phase, participants will have a final safety follow-up visit. The primary purpose of the study is to monitor the effect PKN605 has on the amount of time participants spend in atrial fibrillation.

Atrial Fibrillation
Phase2
Recruiting
165
Oct 28, 2025
Sep 09, 2027
All
18 Years - (Adult, Older Adult)

Interventions

Drug

PKN605

PKN605 is an oral formulation
Other

Placebo

Matching placebo

Eligibility Criteria

Inclusion Criteria:

* Inclusions at Screening

* Signed informed consent must be obtained prior to participation in the study
* Male and female participants ≥ 18 years of age
* History of at least 2 episodes of AF
* At least 1 of the AF episodes specified in inclusion #3 must be within the last 12 months (or during screening) and documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator
* One or more of the following:
* AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months
* CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)
* Stable heart failure or with New York Heart Association class I or II symptoms
* NT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months

* On guideline-directed stroke prevention treatment, as confirmed by the Investigator
* Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated as body weight (kg) divided by height (m) squared
* Inclusions at Day 1

* Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)

Exclusion Criteria:

-Exclusions at Screening

* Permanent AF
* Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)
* Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)
* History of an AF ablation procedure within the last 6 months without a recurrence of AF at least 2 or more months after the ablation.
* Implanted pacemaker, defibrillator, or cardiac monitor
* Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy
* Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening
* Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening

Novartis Investigative Site

Recruiting

Newmarket,Ontario,L3y 2p6,Canada

Novartis Investigative Site

Recruiting

Montreal,Quebec,H1t 1c8,Canada

Novartis Investigative Site

Recruiting

Montreal,Quebec,H2x 1r9,Canada

Novartis Investigative Site

Recruiting

Québec,Quebec,G1v 4g5,Canada

Novartis Investigative Site

Recruiting

Sherbrooke,Quebec,J1h 5n4,Canada

Novartis Investigative Site

Recruiting

Goes,Zeeland,4462 ra,Netherlands

Novartis Investigative Site

Recruiting

Singapore,Singapore,S308433,Singapore

Novartis Investigative Site

Recruiting

Singapore,169609,Singapore

Weill Cornell Medical Center

Recruiting

New York,New York,10021,United States

Jim Way Cheung
Salem Fasil

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Novartis Pharmaceuticals

Novartis Pharmaceuticals