Purpose of this Study
This study lasts for about 41 weeks. It starts with a screening period, followed by around 6 months of taking either the study medicine or a placebo, and ends with a follow-up visit. People who join will be randomly chosen to get either a low dose or high dose of the medicine called PKN605, or a placebo, which is a pill that does not have any medicine in it.
During the study, participants will go to the clinic regularly. They will wear a heart monitor patch, use a small device at home to check their heart, and have blood tests and other health checks. These tests help doctors learn how the medicine works and if it is safe.
Who Can Participate?
Eligibility
Adults who are 18 years old or older may be able to join this study if they have had at least two episodes of atrial fibrillation, which is a problem with how the heart beats. One of these episodes must have been recorded in the past year using a heart test like an ECG.
To qualify, participants must also meet at least one other condition. These include having a score that shows a higher risk of stroke, having atrial fibrillation for at least 1% of the time on a heart monitor, having mild and stable heart failure, or having a certain level of a heart-related protein in their blood.
People cannot join the study if they have permanent atrial fibrillation, certain other heart problems, or if they are currently taking medicines that treat irregular heartbeats.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new medicine called PKN605 to see if it can help people who have atrial fibrillation, which is a problem with how the heart beats. The goal is to find out if the medicine can safely reduce the amount of time people spend in atrial fibrillation and help them feel better. Researchers also want to learn how the medicine moves through the body and how it affects the heart.
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full 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
Principal Investigator
Jonathan
Piccini
Protocol Number
PRO00118549
NCT ID
NCT07217067
Phase
II
Enrollment Status
Pending Open to Enrollment