What this study is
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 fibrillation
What's being tested
- PKN605
Intervention · DRUG
PKN605 is an oral formulation
- Placebo
Intervention · OTHER
Matching placebo
Study details
- Official title
- 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
- Sponsor
- Novartis Pharmaceuticals
- Conditions
- Atrial Fibrillation
- Enrolling
- 165 people
- Starts
- 2025-10-28
- Est. completion
- 2027-09-09
- Design
- Double-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 atrial fibrillation
- AF (atrial fibrillation or atrial flutter) within the last 12 months (or during screening) documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator
- Meets one or more of the following criteria: A. Recurrent AF (≥ 2 episodes), and ≥ 1 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 B. AFB ≥ 1% or an AF episode lasting ≥ 2 h during Screening, including when detected using a study provided ECG patch monitor C. Persistent AF, as confirmed by the Investigator; 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)
You can't join if
- 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 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. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used
- Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (40)
38 openCardiology Associates of North MS
Tupelo, Mississippi, United States
- Brittany Cook · ContactBrittany.cook@nmhs.net
- James Edgar Stone · Principal investigator
RecruitingCooper University Hospital
Camden, New Jersey, United States
- Ifeoluwa Onuoha · Contactonuoha-ifeoluwa@cooperhealth.edu
- Andrea Russo · Principal investigator
RecruitingWeill Cornell Medical Center
New York, New York, United States
- Penn Collins · Contactgpc4001@med.cornell.edu
- Jim Way Cheung · Principal investigator
RecruitingDuke Univ Medical Center
Durham, North Carolina, United States
- Jessalyn Davis · Contactjessalyn.crews@duke.edu
- Jonathan Piccini · Principal investigator
RecruitingIntermountain Medical Center
Murray, Utah, United States
- Paden Hansen · Contactpaden.hansen@imail.org
- Michael Cutler · Principal investigator
RecruitingSwedish Heart and Vascular Clinic
Seattle, Washington, United States
- Serena Risher · Contact+1 206 386 6462Serena.Risher@swedish.org
- David Lam · Principal investigator
Recruiting
34 sites outside the US
Novartis Investigative Site
Calgary, Alberta, Canada
RecruitingNovartis Investigative Site
Vancouver, British Columbia, Canada
RecruitingNovartis Investigative Site
Halifax, Nova Scotia, Canada
RecruitingNovartis Investigative Site
Hamilton, Ontario, Canada
RecruitingNovartis Investigative Site
London, Ontario, Canada
RecruitingNovartis Investigative Site
Newmarket, Ontario, Canada
RecruitingNovartis Investigative Site
Toronto, Ontario, Canada
RecruitingNovartis Investigative Site
Toronto, Ontario, Canada
RecruitingNovartis Investigative Site
Montreal, Quebec, Canada
RecruitingNovartis Investigative Site
Montreal, Quebec, Canada
RecruitingNovartis Investigative Site
Montreal, Quebec, Canada
RecruitingNovartis Investigative Site
Québec, Quebec, Canada
RecruitingNovartis Investigative Site
Sherbrooke, Quebec, Canada
RecruitingNovartis Investigative Site
Beijing, Beijing Municipality, China
RecruitingNovartis Investigative Site
Beijing, China
RecruitingNovartis Investigative Site
Xi'an, China
RecruitingNovartis Investigative Site
Bad Homburg, Germany
RecruitingNovartis Investigative Site
Berlin, Germany
RecruitingNovartis Investigative Site
Berlin, Germany
RecruitingNovartis Investigative Site
Hamburg, Germany
RecruitingNovartis Investigative Site
Hamburg, Germany
RecruitingNovartis Investigative Site
Arnhem, Gelderland, Netherlands
RecruitingNovartis Investigative Site
Maastricht, Limburg, Netherlands
RecruitingNovartis Investigative Site
Goes, Zeeland, Netherlands
RecruitingNovartis Investigative Site
Groningen, Netherlands
RecruitingNovartis Investigative Site
Veldhoven, Netherlands
RecruitingNovartis Investigative Site
Singapore, Singapore, Singapore
RecruitingNovartis Investigative Site
Singapore, Singapore
RecruitingNovartis Investigative Site
Singapore, Singapore
RecruitingNovartis Investigative Site
Brighton, East Sussex, United Kingdom
RecruitingNovartis Investigative Site
Newcastle upon Tyne, Tyne and Wear, United Kingdom
RecruitingNovartis Investigative Site
London, United Kingdom
RecruitingNovartis Investigative Site
Delft, South Holland, Netherlands
WithdrawnNovartis Investigative Site
Liverpool, United Kingdom
Withdrawn
Study team
Sponsor
Novartis Pharmaceuticals
Study ID CPKN605A12201
Study director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.