Follow up of Ticagrelor Treatment Patterns in Chinese Acute Coronary Syndromes Patients

Acute Coronary Syndrome Clinical Trial

Official title:

Follow up of Ticagrelor Treatment Patterns in Chinese Acute Coronary Syndromes Patients- A Database Retrospective Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04861363
• Other study ID #: ESR-18-13975
• Status: Enrolling by invitation
• Start date: June 19, 2019
• Est. completion date: July 19, 2021

Study information

• Verified date: April 2021
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Background： There are at least 2.5 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 discontinuation/switching/interruption 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 switching/discontinuation/interruption

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 Ticagrelor/Clopidogrel 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20000
• Est. completion date: July 19, 2021
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. ACS patients hospitalized during the following period: from January 2019 to September 2019

2. Patients receiving ticagrelor as part of DAPT at hospital discharge.

3. Patient enrolled into the follow-up program of ACS patients

Exclusion Criteria:

Patients participated in other interventional clinical trials

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Division of Cardiology, Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, Wong PK. Medication compliance and persistence: terminology and definitions. Value Health. 2008 Jan-Feb;11(1):44-7. doi: 10.1111/j.1524-4733.2007.00213.x. Review. — View Citation

Hao Y, Liu J, Liu J, Smith SC Jr, Huo Y, Fonarow GC, Ma C, Ge J, Taubert KA, Morgan L, Guo Y, Zhang Q, Wang W, Zhao D; CCC-ACS Investigators. Rationale and design of the Improving Care for Cardiovascular Disease in China (CCC) project: A national effort to prompt quality enhancement for acute coronary syndrome. Am Heart J. 2016 Sep;179:107-15. doi: 10.1016/j.ahj.2016.06.005. Epub 2016 Jun 18. — View Citation

Sun Y, Li C, Zhang L, Hu D, Zhang X, Yu T, Tao M, Wang DW, Shen X. Poor adherence to P2Y12 antagonists increased cardiovascular risks in Chinese PCI-treated patients. Front Med. 2017 Mar;11(1):53-61. doi: 10.1007/s11684-017-0502-2. Epub 2017 Mar 2. — View Citation

Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Jüni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. — View Citation

Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators, Freij A, Thorsén M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30. — View Citation

Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009 Nov-Dec;15(9):728-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ticagrelor persistence	Duration of ticagrelor treatment: Proportion of patients receiving ticagrelor each month after discharge; Duration from the start of treatment to the end of treatment.	12 months
Primary	Ticagrelor discontinuation and reasons for discontinuation	Percentage of patients with ticagrelor discontinuation and related causes: Discontinuation was defined as stopping P2Y12 for at least 3 months.	12 months
Primary	Ticagrelor switch and reasons for switching	Percentage of patients with ticagrelor change and related causes: Switching refers to switching from ticagrelor/clopidogrel to another P2Y12 inhibitor (switching from clopidogrel to ticagrelor is a redressing, if documented)	12 months
Primary	Ticagrelor interruption and reasons for interruption	Percentage of patients with ticagrelor interruption and related causes: Interruptionn was defined as drug withdrawal for more than 1 day and less than 3 months.	12 months
Primary	Major Adverse Cardiovascular Events	Time to the first occurence of Any cause death, myocardial infarction, or Stroke	12 months
Secondary	Any cause death	Time to the occurence of Any cause death	12 months
Secondary	Myocardial infarction	Time to the first occurence of Myocardial infarction	12 months
Secondary	Stroke	Time to the first occurence of Stroke	12 months