Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats
NCT Number: NCT06501638
Acronym: STOP-AP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atrial Premature Beats, Contractions, or Systoles
Interventions: DRUG: Memantine Hydrochloride 10 MG|DRUG: Placebo
Sponsor: Shanghai East Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 256
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-07
Completion Date: 2025-12-31
Locations: Shanghai East hospital, Shanghai, Shanghai, 200120, China

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.

Primary Outcome Measures: 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 Outcome Measures: 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), 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), 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), 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), 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), The fourth, sixth and eighth week after intervention|change of 24-hour sustained atrial tachycardia, atrial flutter and atrial fibrillation burden, Participants accepted 3-day holter patch monitor at baseline, fourth, sixth and eighth week after intervention. Average sustained atrial tachycardia, atrial flutter and atrial fibrillation burden was then calculated.

change of 24-hour sustained atrial tachycardia, atrial flutter and atrial fibrillation burden=newly discovered 24-hour sustained atrial tachycardia, atrial flutter and atrial fibrillation burden (observation time), The fourth, sixth and 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), The sixth week after intervention