Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04861363
Status:
UNKNOWN
Last Update Posted:
2021-04-27
First Post:
2021-04-10
Brief Title:
Follow up of Ticagrelor Treatment Patterns in Chinese Acute Coronary Syndromes Patients
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
Follow up of Ticagrelor Treatment Patterns in Chinese Acute Coronary Syndromes Patients- A Database Retrospective Study
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
This is a retrospective observational descriptive study which will include patients hospitalized for acute coronary syndrome ACS and treated with ticagrelor at discharge Participants will come from the follow-up program of ACS patients taking ticagrelor 90 mg twice a day as part of the dual antiplatelet therapy at discharge The primary objectives were to describe the ticagrelor treatment patterns-Ticagrelor persistence discontinuation switching interruption and reasons in Chinese ACS patients and also to describe 1-year clinical outcomes Composite of any cause death myocardial infarction and stroke of Chinese ACS patients in real-life practice based on ACS patient follow-up program database
Detailed Description:
Background There are at least 25 million acute coronary syndromes ACS patients in China per year Limited data about long term ticagrelor treatment patterns and clinical outcomes in Chinese ACS patients due to the lack of large high quality follow up database This study is based on real-life practice and ticagrelor is prescribed according to the Chinese guideline and it takes place in real life
Objective of this study
Primary Objectives
1 To describe the ticagrelor treatment patterns-Ticagrelor persistence discontinuation switching interruption and reasons for discontinuationswitchinginterruption in Chinese ACS patients
2 To describe 1-year clinical outcomes Composite of any cause death myocardial infarction and stroke of Chinese ACS patients in real-life practice based on ACS patient follow-up program database
Secondary Objectives
1 To describe the impact of ticagrelor treatment pattern on clinical outcomes No confirmed conclusions regarding the efficacy or impact of ticagrelor treatment patterns will be drawn because of descriptive analysis
2 To analyze influence factors age region hypertension diabetes chronic kidney disease CKD smoking education insurance etc related to clinical outcomes
Exploratory Objectives
To explore the influence factors age region education insurance event etc with ticagrelor treatment pattern Analysis of other possible factors such as smoke low density lipoprotein-chlesterol LDL-C affecting the prognosis of patients with ACS Analysis of possible interactions and their influences between different factors associated with the prognosis of patients with ACS
Study design
This is a retrospective observational descriptive study which will include patients hospitalized for ACS and treated with ticagrelor at discharge
Data source
Study participants Participants will come from the follow-up program of ACS patients taking ticagrelor 90 mg twice a day as part of the dual antiplatelet therapy at discharge During the follow-up period for 12 months after discharge Telephone follow-up will be done 1 3 6 12 months after discharge according to a structured questionnaire assessing the primary and secondary objectives of this study Telephone interviews will be performed by the local ACS patient follow-up program assistants nurses who enters information in the websites
Study Variables
Primary variables
1 Ticagrelor treatment patterns-Ticagrelor persistence discontinuation switch interruption and reasons for switchingdiscontinuationinterruption
1 Ticagrelor persistence Proportion of patients who is on ticagrelor treatment every month after discharge Duration of time from initiation to discontinuation of therapy
2 Proportion of patients with ticagrelor discontinuation switching and interruption and related reasons Discontinuation of medications was defined as a break for P2Y12 at least three months Switching means from TicagrelorClopidogrel to another P2Y12 inhibitor Clopidogrel to ticagrelor means re-switching if they were recorded Interruption was defined as Ticagrelor discontinuation for more than 1 day and less than 3 months 2 Time to first occurrence of any of the following clinical events Composite of any cause death myocardial infarction Stroke within one year follow up
Secondary variables
1 Time to the first occurrence of each component of primary clinical events any cause death myocardial infarction Stroke in the first year after discharge
2 Proportion of ticagrelor treatment patterns with different clinical outcomes
3 Correlation between risk factors age region education insurance hypertension diabetes CKD smoking etc and clinical outcomes
Exploratory variables
Association between ticagrelor persistence and risk factors regions education reimbursement etc Analysis of other possible factors such as smoke LDL-C etc affecting the prognosis of patients with ACS Analysis of possible interactions and their influences between different factors associated with the prognosis of patients with ACS
Exposures of Interest
Ticagrelor 90 mg used twice a day as part of dual antiplatelet therapy DAPT during first year after ACS
Outcomes of Interest
1 Ticagrelor treatment patterns -Persistence discontinuation rate switching and interruption in Chinese ACS patients after hospital discharge
2 Time of first occurrence of any of the end-point events any cause death myocardial infarction Stroke within one year follow up
Limitations
The study subjects are patients under ticagrelor treatment at discharge in China which limits the generalization of the study results The criteria for patients treated with ticagrelor might lead to patient selection bias As some risk factors of cardiovascular disease CVD were not randomized there might be unmeasured confounding
Objective of this study
Primary Objectives
1 To describe the ticagrelor treatment patterns-Ticagrelor persistence discontinuation switching interruption and reasons for discontinuationswitchinginterruption in Chinese ACS patients
2 To describe 1-year clinical outcomes Composite of any cause death myocardial infarction and stroke of Chinese ACS patients in real-life practice based on ACS patient follow-up program database
Secondary Objectives
1 To describe the impact of ticagrelor treatment pattern on clinical outcomes No confirmed conclusions regarding the efficacy or impact of ticagrelor treatment patterns will be drawn because of descriptive analysis
2 To analyze influence factors age region hypertension diabetes chronic kidney disease CKD smoking education insurance etc related to clinical outcomes
Exploratory Objectives
To explore the influence factors age region education insurance event etc with ticagrelor treatment pattern Analysis of other possible factors such as smoke low density lipoprotein-chlesterol LDL-C affecting the prognosis of patients with ACS Analysis of possible interactions and their influences between different factors associated with the prognosis of patients with ACS
Study design
This is a retrospective observational descriptive study which will include patients hospitalized for ACS and treated with ticagrelor at discharge
Data source
Study participants Participants will come from the follow-up program of ACS patients taking ticagrelor 90 mg twice a day as part of the dual antiplatelet therapy at discharge During the follow-up period for 12 months after discharge Telephone follow-up will be done 1 3 6 12 months after discharge according to a structured questionnaire assessing the primary and secondary objectives of this study Telephone interviews will be performed by the local ACS patient follow-up program assistants nurses who enters information in the websites
Study Variables
Primary variables
1 Ticagrelor treatment patterns-Ticagrelor persistence discontinuation switch interruption and reasons for switchingdiscontinuationinterruption
1 Ticagrelor persistence Proportion of patients who is on ticagrelor treatment every month after discharge Duration of time from initiation to discontinuation of therapy
2 Proportion of patients with ticagrelor discontinuation switching and interruption and related reasons Discontinuation of medications was defined as a break for P2Y12 at least three months Switching means from TicagrelorClopidogrel to another P2Y12 inhibitor Clopidogrel to ticagrelor means re-switching if they were recorded Interruption was defined as Ticagrelor discontinuation for more than 1 day and less than 3 months 2 Time to first occurrence of any of the following clinical events Composite of any cause death myocardial infarction Stroke within one year follow up
Secondary variables
1 Time to the first occurrence of each component of primary clinical events any cause death myocardial infarction Stroke in the first year after discharge
2 Proportion of ticagrelor treatment patterns with different clinical outcomes
3 Correlation between risk factors age region education insurance hypertension diabetes CKD smoking etc and clinical outcomes
Exploratory variables
Association between ticagrelor persistence and risk factors regions education reimbursement etc Analysis of other possible factors such as smoke LDL-C etc affecting the prognosis of patients with ACS Analysis of possible interactions and their influences between different factors associated with the prognosis of patients with ACS
Exposures of Interest
Ticagrelor 90 mg used twice a day as part of dual antiplatelet therapy DAPT during first year after ACS
Outcomes of Interest
1 Ticagrelor treatment patterns -Persistence discontinuation rate switching and interruption in Chinese ACS patients after hospital discharge
2 Time of first occurrence of any of the end-point events any cause death myocardial infarction Stroke within one year follow up
Limitations
The study subjects are patients under ticagrelor treatment at discharge in China which limits the generalization of the study results The criteria for patients treated with ticagrelor might lead to patient selection bias As some risk factors of cardiovascular disease CVD were not randomized there might be unmeasured confounding
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?:
False
Is an FDA AA801 Violation?:
None