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A study to investigate the efficacy, safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation
EU CTIS ID: 2025-520518-79-00
What this study is testing
To evaluate the effect of PKN605 on atrial fibrillation burden
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrilation
- At least one 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, at Screening: • 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, 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, at Screening
You likely can't join if
- Permanent AF
- Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, alcohol use, sepsis- or infection-related AF, surgery-related AF, pulmonary embolism)
- Ongoing use of antiarrhythmic therapy (Vaughan Williams class l 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
See the full eligibility criteria
Who can join
- 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 (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrilation
- At least one 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, at Screening: • 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, 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, at Screening
- Participants must have a body mass index (BMI) >18 kg/m2. BMI is calculated as body weight (kg) divided by height in (m) squared
- Sinus rhythm at Baseline as documented by a 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)
What rules you out
- Permanent AF
- Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, alcohol use, sepsis- or infection-related AF, surgery-related AF, pulmonary embolism)
- Ongoing use of antiarrhythmic therapy (Vaughan Williams class l 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
- Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening
- Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during the Screening period. If multiple LVEF measurements are recorded within last 12 months, the most recent LVEF measurement should be used.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Singapore
- China
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Singapore; China; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.