Atrial Fibrillation study: PKN605
Official title A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation
ClinicalTrials.gov ID: NCT07217067
What this study is testing
What is PKN605?
PKN605 is an investigational medicine, taken by mouth monthly, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether PKN605 can lower the amount of atrial fibrillation and to assess its safety and how the body processes the drug.
- Who it's for
- Adults who have atrial fibrillation.
- What's involved
- Participants are randomly assigned to receive either PKN605 or a placebo, without knowing which they get, and will have regular check‑ups and tests to monitor heart rhythm and drug levels.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely 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...
- Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening...
- 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
See the full eligibility 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 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
- 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
- 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.
- 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)
- -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
- 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.
- Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening
The study team makes the final eligibility decision.
Where it is enrolling
- Tupelo, Mississippi, United States
- Camden, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Murray, Utah, United States
- Seattle, Washington, United States
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Beijing, Beijing Municipality, China
- Beijing, China
- Xi'an, China
- Bad Homburg, Germany
+ 12 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tupelo, Mississippi, United States; Camden, New Jersey, United States; New York, New York, United States; Durham, North Carolina, United States; Murray, Utah, United States; Seattle, Washington, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.