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

NCT06501638 | Completed Phase 2 DMC

• 1 other identifier: 2024YS-146
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Premature Beats, Contractions, or Systoles

Keywords

Atrial Premature Beats; memantine; double-blinded; randomized; placebo control

Outcome Measures

Primary Outcomes (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)

  The sixth week after intervention

Secondary Outcomes (10)

• change of 24-hour premature atrial beats count

  The fourth, sixth and eighth week after intervention

• change of 24-hour premature atrial beats burden

  The fourth, sixth and eighth week after intervention

• change of 24-hour non-sustained atrial tachycardia episodes

  The fourth, sixth and eighth week after intervention

• change of 24-hour non-sustained atrial tachycardia burden

  The fourth, sixth and eighth week after intervention

• change of 24-hour sustained atrial tachycardia, atrial flutter and atrial fibrillation episodes

  The fourth, sixth and eighth week after intervention

Study Arms (2)

Memantine

EXPERIMENTAL

Take Memantine Hydrochloride for intervention

Drug: Memantine Hydrochloride 10 MG

Placebo

PLACEBO COMPARATOR

Take placebo for intervention

Drug: Placebo

Interventions

Memantine Hydrochloride 10 MG DRUG

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

Memantine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Atrial Premature Complexes

Interventions

Memantine

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yihan Chen, Doctor

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: August 29, 2024
• Primary Completion: March 21, 2025
• Study Completion: May 16, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)