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Etripamil for Atrial Fibrillation
Study Summary
This trial demonstrates that etripamil is more effective than placebo in reducing ventricular rate for AF patients, and is safe and well tolerated.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 199 Patients • NCT02296190Trial Design
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Who is running the clinical trial?
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- You have had a stroke, mini-stroke, or blood clot in your limbs within the past 3 months.You have a serious narrowing in your heart valves that has not been fixed.You have a serious health condition that could put your safety at risk or affect the accuracy of the study results.If you have atrial fibrillation, you need to be receiving the right medication to prevent blood clots, as recommended by your doctor.You have a history of a type of heart block called second- or third-degree atrioventricular block.You have a history or signs of certain heart rhythm problems called torsades de pointes, sick sinus syndrome, or Brugada syndrome.The study drug etripamil is only used for short-term heart rate control. If you need long-term control of your heart rhythm, you may require additional medications and blood thinners as per medical guidelines.Your heart beats in a regular rhythm that indicates a complete block in the electrical signals between the upper and lower chambers of the heart.You had a heart attack in the past year, unless you had a successful procedure to fix it.You have had an allergic reaction to any parts of the experimental medication.You are showing serious signs of heart failure, like difficulty breathing, low oxygen levels, crackling sounds in your lungs, and poor blood circulation in your extremities.You have had a bad reaction to verapamil in the past.
- Group 1: Etripamil
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the maximum capacity of participants for this trial?
"80 participants that meet the predetermined requirements are required to join this clinical trial. The locations of Hamilton Health Science in Hamilton, Nova Scotia and QEII HSC - Nova Scotia Health Authority in Halifax, Quebec both offer participation opportunities for interested patients."
How many centers are overseeing the implementation of this research?
"15 medical centres are participating in this trial, including Hamilton Health Science in Hamilton, QEII HSC - Nova Scotia Health Authority in Halifax, and Ottawa Hospital General & Civic Campus Research Institute in Ottawa. Additionally, there are 12 other sites throughout the country."
Is this research currently accessible to participants?
"Affirmative, the information hosted on clinicaltrials.gov indicates that this research project is currently accepting candidates. This trial was first made available on November 19th 2020 and its details have been refreshed as of August 2nd 2022. 80 volunteers will be recruited from 15 different sites for participation in this study."
Could you please elucidate the potential perils of Etripamil?
"Our team at Power has assigned a safety score of 2 to etripamil due to the fact that it is currently undergoing Phase 2 clinical trials, with prior evidence pointing towards its safety but no efficacy data available yet."
Has Etripamil been studied in the context of other clinical research efforts?
"At present, there are two studies being conducted on the efficacy of Etripamil. One is at a Phase 3 level and though based in Arnhem, Ontario; 36 different clinical trial sites are participating worldwide."
Is this the inaugural endeavor of its type?
"Research into the efficacy of etripamil began in 2020, when JSS Medical Research Inc. ran its first study with 80 participants. After receiving Phase 2 drug approval following this trial, there are currently two active studies for etripamil being conducted across multiple cities and countries.."
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