A Phase 2 interventional study of Memantine Hydrochloride 10 MG and Placebo in Atrial Premature Beats, Contractions, or Systoles, sponsored by Shanghai East Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Shanghai East Hospital · Phase 2, Interventional, and Treatment
A multicenter, randomized, double-blind, placebo-controlled study to expIore the efficacy and safety of Memantine hydrochIoride tabIets to treat patients with frequent PACs.
After preliminary screening, the target patients will undergo continuous 3-day (72-hour) monitoring with a wearable holter patch(as baseline data) to assess the number of baseline atrial premature beats. Based on the monitored data, it will be determined whether the subjects meet the inclusion criteria. Eligible participants will be randomly assigned in a 1:1 ratio (on Day 0) to either the experimental group (administered with hydrochloride memantine tablets) or the control group (placebo). A total of 256 subjects will be enrolled, with 128 subjects in each group, stratified by age (age ≥ 65 years vs. age \< 65 years) and the number of atrial premature beats (≥ 5000 beats/24h vs. \< 5000 beats/24h).
The subjects in the experimental group will take hydrochloride memantine tablets according to the following regimen:Week 1: Half tablet per dose (5mg/dose), twice daily, taken orally at the same time in the morning and evening (with a recommended dosing interval of 12 hours ± 2 hours).Week 2 to Week 6: One tablet per dose (10mg/dose), twice daily, taken orally at the same time in the morning and evening (with a recommended dosing interval of 12 hours ± 2 hours).
Control group (placebo): The subjects in the control group will take placebo according to the following regimen:Week 1: Half tablet per dose, twice daily, taken orally at the same time in the morning and evening (with a recommended dosing interval of 12 hours ± 2 hours).Week 2 to Week 6: One tablet per dose, twice daily, taken orally at the same time in the morning and evening (with a recommended dosing interval of 12 hours ± 2 hours).
The study consists of a screening period (D0-D7 days), a treatment period (D8-D42 days), and a follow-up period (D43-D56 days).The start dates for the 3-day ambulatory holter patch are as follows: D25-D28, D39-D42, and D53-D56.
26 studies on the registry are indexed under Atrial Premature Complexes; 6 are open to participants now.
This study's enrollment of 256 is above the median of 108 across 13 interventional studies indexed under Atrial Premature Complexes.
Browse Atrial Premature Complexes studies →Shanghai East Hospital is the lead sponsor of 92 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Take Memantine Hydrochloride for intervention
Drug: Memantine Hydrochloride 10 MG
Take placebo for intervention
Drug: Placebo
Take Memantine Hydrochloride for intervention First week, 5mg(half the tablet), p.o.，bid. Second to Sixth week, 10mg(one tablet), p.o., bid
Take placebo for intervention First week, half the tablet, p.o., bid. Second to Sixth week, one tablet, p.o., bid
percentage reduction of 24-hour premature atrial beats count
Participants accepted 3-day holter patch monitor at baseline, fourth, sixth and eighth week after intervention. Average 24-hour premature atrial beats count was then calculated. percentage reduction of 24-hour premature atrial beats count = (24-hour premature atrial beats count(baseline)-24-hour premature atrial beats count (sixth week) ) /24-hour premature atrial beats count(baseline)
Time frame: The sixth week after intervention
change of 24-hour premature atrial beats count
Participants accepted 3-day holter patch monitor at baseline, fourth, sixth and eighth week after intervention. Average 24-hour premature atrial beats count was then calculated. change of 24-hour premature atrial beats count =24-hour premature atrial beats count(baseline)-24-hour premature atrial beats count (observation time)
Time frame: The fourth, sixth and eighth week after intervention
change of 24-hour premature atrial beats burden
Participants accepted 3-day holter patch monitor at baseline, fourth, sixth and eighth week after intervention. Average 24-hour premature atrial beats burden was then calculated. change of 24-hour premature atrial beats burden =24-hour premature atrial beats burden(baseline)-24-hour premature atrial beats burden (observation time)
Time frame: The fourth, sixth and eighth week after intervention
change of 24-hour non-sustained atrial tachycardia episodes
Participants accepted 3-day holter patch monitor at baseline, fourth, sixth and eighth week after intervention. Average 24-hour premature atrial beats episodes was then calculated. change of 24-hour non-sustained atrial tachycardia episodes=24-hour non-sustained atrial tachycardia episodes (baseline)- 24-hour non-sustained atrial tachycardia episodes (observation time)
Time frame: The fourth, sixth and eighth week after intervention
change of 24-hour non-sustained atrial tachycardia burden
Participants accepted 3-day holter patch monitor at baseline, fourth, sixth and eighth week after intervention. Average 24-hour non-sustained atrial tachycardia burden was then calculated. change of 24-hour non-sustained atrial tachycardia burden =24-hour non-sustained atrial tachycardia burden(baseline)- 24-hour non-sustained atrial tachycardia burden (observation time)
Time frame: The fourth, sixth and eighth week after intervention
change of 24-hour sustained atrial tachycardia, atrial flutter and atrial fibrillation episodes
Participants accepted 3-day holter patch monitor at baseline, fourth, sixth and eighth week after intervention. Average 24-hour sustained atrial tachycardia, atrial flutter and atrial fibrillation episodes was then calculated. change of 24-hour non-sustained atrial tachycardia episodes=newly discovered 24-hour non-sustained atrial tachycardia episodes (observation time)
Time frame: The fourth, sixth and eighth week after intervention
The proportion of new-onset persistent atrial tachycardia, atrial fibrillation (AF), and atrial flutter during continuous 72-hour monitoring at weeks 4, 6, and 8
The proportion of subjects with persistent atrial tachycardia, AF, and atrial flutter ≥ 30 seconds first recorded during the planned continuous 72-hour electrocardiographic monitoring at weeks 4, 6, and 8.This endpoint will be calculated based on the first occurrence of SAT, AF, or AFL during the respective 72-hour monitoring windows;
Time frame: The fourth, sixth and eighth week after intervention
Cumulative incidence of new-onset AF from week 0 to week 8:
the proportion of subjects with AF ≥ 30 seconds first recorded at any follow-up window at weeks 4, 6, and 8 from randomization to the end of week 8. If the same subject has AF at weeks 4, 6, the first occurrence of AF is counted as one case, with a maximum of one count per subject
Time frame: The eighth week after intervention
SF-36 score change
Participants accepted the Mos 36-item Short Form Health Survey evaluation at baseline and sixth after intervention. SF-36 score change= SF-36 score (baseline)-SF-36 score (sixth week)
Time frame: The sixth week after intervention
Efficacy analysis of atrial premature beats or non-sustained atrial tachycardia
Efficacy Criteria for Atrial Premature Beats Treatment: A reduction of ≥50% in the average number of atrial premature beats over 24 hours compared to baseline after taking the study drug (Memantine Hydrochloride Tablets or placebo). Efficacy Criteria for Non-sustained Atrial Tachycardia Treatment: A reduction of ≥50% in the average burden of non-sustained atrial tachycardia over 24 hours compared to baseline after taking the study drug (Memantine Hydrochloride Tablets or placebo).
Time frame: The fourth, sixth and eighth week after intervention
Safety profile of memantine in patients with frequent symptomatic PACs
The incidence of adverse events (including psychiatric symptoms, seizures, bradycardia, new-onset heart failure, etc.), serious adverse events, laboratory test abnormalities, and abnormal electrocardiogram findings.
Time frame: The eighth week after intervention
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Shanghai East Hospital