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Atrial Premature Beats, Contractions, or SystolesPhase 2STOP-APNCT06501638

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

A Phase 2 study testing Memantine Hydrochloride 10 MG in people with Atrial Premature Beats, Contractions, or Systoles, run by Shanghai East Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Memantine Hydrochloride 10 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
1 siteChina
Study dates
29 Aug 2024to 16 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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).
  • Severe renal insufficiency (calculated estimated glomerular filtration rate [eGFR] <40 ml/min/1.73m² using the CKD-EPI equation).
  • Received investigational drugs or medical device treatments in other clinical trials within 1 month prior to screening or within 5 half-lives (whichever is longer).
  • Pregnancy, lactating women, or positive pregnancy test result before randomization.
  • Hyperthyroidism that has not been properly treated and thyroid function has not returned to normal, the perioperative period of cardiothoracic surgery (one week before surgery to two weeks after surgery), uncorrected electrolyte disturbances (serum K+ > 5.5 mmol/L or < 3.5 mmol/L, serum magnesium < 1.5 mmol/L, etc.); chronic obstructive pulmonary disease (COPD) combined with respiratory failure or infection that has not been corrected, etc.
  • History of epilepsy, seizures, or mental illness.
  • Known allergy to memantine hydrochloride tablets or their excipients.
  • Patients currently receiving memantine treatment for moderate or severe Alzheimer's disease.
  • Other circumstances where the investigator deems the subject unsuitable for inclusion in the study.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats: a Multicenter Randomized Double-blind Placebo-controlled Study

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

Read the detailed description

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.

Being tested
Memantine Hydrochloride 10 MG, Placebo
Keywords
Atrial Premature Beats, memantine, double-blinded, randomized, placebo control
Medical subject headings
Atrial Premature Complexes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Memantine Hydrochloride 10 MGDrug

    Take Memantine Hydrochloride for intervention First week, 5mg(half the tablet), p.o.,bid. Second to Sixth week, 10mg(one tablet), p.o., bid

  • PlaceboDrug

    Take placebo for intervention First week, half the tablet, p.o., bid. Second to Sixth week, one tablet, p.o., bid

Study groups in NCT06501638
Study groupRoleWhat they receive
MemantineExperimentalTake Memantine Hydrochloride for intervention
Receives: Drug: Memantine Hydrochloride 10 MG
PlaceboPlacebo comparatorTake placebo for intervention
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: The sixth week after intervention

Secondary outcomes (10)
  1. 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)

    Measured: The fourth, sixth and eighth week after intervention

  2. 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)

    Measured: The fourth, sixth and eighth week after intervention

  3. 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)

    Measured: The fourth, sixth and eighth week after intervention

  4. 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)

    Measured: The fourth, sixth and eighth week after intervention

  5. 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)

    Measured: The fourth, sixth and eighth week after intervention

  6. 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;

    Measured: The fourth, sixth and eighth week after intervention

  7. 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

    Measured: The eighth week after intervention

  8. 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)

    Measured: The sixth week after intervention

  9. 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).

    Measured: The fourth, sixth and eighth week after intervention

  10. 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.

    Measured: The eighth week after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start29 Aug 2024
  3. Primary completion21 Mar 2025
  4. Study completion16 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06501638
Sponsor's protocol ID
2024YS-146
Acronym
STOP-AP
Status last verified
Oct 2025
First submitted
9 Jul 2024
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shen Y, Zeng C, Sun Y, Wang J, Yu B, Cheng X, Guo X, Wang DW, Li Y, Han W, Zhou B, Sheng H, Huang Z, Li Y, Fu G, Zhang J, Xie D, Liang D, Liu Y, Yang B, Zhang Q, Duan R, Li H, Zhang B, Wu Y, Zheng L, He J, Liu S, Yin D, Sun G, Zhang S, Guo X, Zhang M, Wang Y, Hu X, Zeng J, Yang X, Li S, Li N, Hu F, Wang H, Hu X, Wang Y, Zeng C, Wang K, Yang J, Wang Y, Lai J, Wang L, Xiong K, Wang G, Zou Q, Shao B, Chen Z, Wu Y, Leng J, Pu J, Ma C, Chen YH. Memantine for Premature Atrial Contractions: A Phase 2 Randomized Clinical Trial. Circulation. 2026 Apr 21;153(16):1196-1209. doi: 10.1161/CIRCULATIONAHA.125.079023. Epub 2026 Mar 19.

    PubMed 41853846

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Memantine Hydrochloride 10 MG in people with Atrial Premature Beats, Contractions, or Systoles, run by Shanghai East Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage reduction of 24-hour premature atrial beats count (time frame: The sixth week after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06501638, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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