A clinical Randomized Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation.
The key goal of this clinical trial is to assess the effectiveness of different doses of AP31969 in lowering Atrial Fibrillation (AF) burden and its safety. Participants will be randomly assigned to one of the following groups: * AP31969 at 100 mg, 200 mg, or 350 mg doses * AP31969 500 mg (not included at the trial start) * Placebo (inactive treatment and has no active properties). The placebo group serves as the comparator for AP31969. All treatments are given orally, twice daily. The trial includes 3 periods: screening (up to 4 weeks), treatment (12 weeks), and follow-up (30 days). The duration of the trial for a participant is approximately 20 weeks. Participants will receive an implantable loop recorder and undergo assessments during the visits at specific times, for example blood and urine analyses, and electrocardiogram.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Atrial fibrillation burden
Measured through implantable loop recorder. Calculated as the amount of time with AF relative to the amount of time the participant is under observation (expressed as a %).
Time frame: From week 2 to week 12
Number of atrial fibrillation episodes
Measured through implantable loop recorder.
Time frame: From week 2 to week 12
Change from baseline in Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT)
Patient reported outcome.
Time frame: Week 12
Number of ventricular tachycardia episodes > 30 seconds of duration
Measured through implantable loop recorder.
Time frame: From week 0 to week 12
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UMHAT "Sveti Georgi" EAD, Department of Invasive Cardiology
Plovdiv, PD, Bulgaria
NOT_YET_RECRUITINGAcibadem City Clinic, Cardiology Department
Sofia, SOF, Bulgaria
RECRUITINGMHAT National Cardiology Hospital EAD, Cardiology Department
Sofia, SOF, Bulgaria
WITHDRAWNAleksandrovska University Hospital, Clinic of Cardiology
Sofia, SOF, Bulgaria
NOT_YET_RECRUITINGSHATC Cardiolife, Invasive Cardiology
Varna, VAR, Bulgaria
RECRUITINGMedical Center Nova Clinic
Varna, VAR, Bulgaria
RECRUITINGUniversity Hospital Herlev and Gentofte Department of Cardiology
Hellerup, Denmark
RECRUITINGViborg Hospital, Department of Cardiology
Viborg, Denmark
RECRUITINGSana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere Medizin
Coburg, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, Nephrologie
Frankfurt, Germany
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