CompletedPhase 2

Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats

China256 participantsStarted 2024-08-29

Plain-language summary

A multicenter, randomized, double-blind, placebo-controlled study to expIore the efficacy and safety of Memantine hydrochIoride tabIets to treat patients with frequent PACs.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age between 18 and 80 (inclusive).
✓. Presence of symptoms related to premature atrial contractions (PACs) during screening, with PACs occurring ≥1000 times/24 hours.
✓. Understanding and willingness to comply with the study procedures and methods, voluntary participation in the study, and signing an informed consent form.

Exclusion criteria

✕. Atrial fibrillation, atrial flutter, or persistent atrial tachycardia (confirmed by electrocardiogram within the past 6 months or detected by continuous 3-day (72h) monitoring with a wearable Holter monitor at baseline); or ventricular tachycardia (excluding occasional short episodes of ventricular tachycardia during sleep) or ventricular fibrillation.
✕. Occurrence of a stroke event, including hemorrhagic/ischemic stroke and transient ischemic attack (TIA), within the past 6 months prior to screening; history of cardiac surgery, myocardial infarction (MI), percutaneous coronary intervention (PCI), or atrial arrhythmia radiofrequency ablation within the past 3 months prior to screening.
✕. Left ventricular ejection fraction (LVEF) ≤40%; or New York Heart Association (NYHA) functional class III or IV.
✕. Sick sinus syndrome, second-degree type II or higher atrioventricular block, or bifascicular block without permanent pacemaker implantation.
✕. Ongoing use of amiodarone within the past 4 weeks prior to screening, or ongoing use of antiarrhythmic drugs other than amiodarone, as well as Chinese herbal medicine with antiarrhythmic effects within the past 1 weeks prior to screening.
✕. Presence of unstable angina, severe congenital heart disease (excluding patent foramen ovale), post-artificial heart valve replacement, acute myocarditis, acute endocarditis, rheumatic heart valve disease,Hypertrophic obstructive cardiomyopathy.
✕. Coexistence of other diseases with an expected survival period of less than 1 year.
✕. Active hepatitis or significant liver dysfunction (ALT or AST \>3 times the upper limit of normal \[ULN\], TBIL \>3 ULN).

What they're measuring

percentage reduction of 24-hour premature atrial beats count

Timeframe: The sixth week after intervention

Trial details

NCT IDNCT06501638

SponsorShanghai East Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-21

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