Ignite Creation Date:
2024-07-17 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501638
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats
Sponsor:
Shanghai East Hospital
Organization:
Shanghai East Hospital
Study Overview
Official Title:
Efficacy and Safety of memanTine in the Treatment Of Frequently symPtomatic Atrial Premature Beats a Multicenter Randomized Double-blind Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP-AP
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
Detailed Description:
After preliminary screening the target patients will undergo continuous 3-day 72-hour monitoring with a wearable holter patchas 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 11 ratio on Day 0 to either the experimental group administered with hydrochloride amiodarone 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 beats24h vs 5000 beats24h
The subjects in the experimental group will take hydrochloride amiodarone tablets according to the following regimenWeek 1 Half tablet per dose 5mgdose twice daily taken orally at the same time in the morning and evening with a recommended dosing interval of 12 hours 2 hoursWeek 2 to Week 6 One tablet per dose 10mgdose 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 regimenWeek 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 hoursWeek 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 daysThe start dates for the 3-day ambulatory holter patch are as follows D25-D28 D39-D42 and D53-D56
The subjects in the experimental group will take hydrochloride amiodarone tablets according to the following regimenWeek 1 Half tablet per dose 5mgdose twice daily taken orally at the same time in the morning and evening with a recommended dosing interval of 12 hours 2 hoursWeek 2 to Week 6 One tablet per dose 10mgdose 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 regimenWeek 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 hoursWeek 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 daysThe start dates for the 3-day ambulatory holter patch are as follows D25-D28 D39-D42 and D53-D56
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None