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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.
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:
Secondary Objectives:
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
Secondary variables:
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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Major Adverse Cardiovascular Events | Time to the first occurence of Any cause death, myocardial infarction, or Stroke | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Any cause death | Time to the occurence of Any cause death | 12 months |
| Myocardial infarction | Time to the first occurence of Myocardial infarction |
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Inclusion Criteria:
Exclusion Criteria:
Patients participated in other interventional clinical trials
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ACS patients taking ticagrelor 90 mg twice a day as part of the dual antiplatelet therapy at discharge
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| Name | Affiliation | Role |
|---|---|---|
| Yong Huo, M.D. | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Peking University First Hospital | Beijing | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27595685 | Background | 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. | |
| 28886622 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 12 months |
| Stroke | Time to the first occurence of Stroke | 12 months |
| Background |
| Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni 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. No abstract available. |
| 19717846 | Background | 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, Thorsen 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. |
| 28213881 | Background | 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. |
| 19954264 | Background | 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. doi: 10.18553/jmcp.2009.15.9.728. |
| 18237359 | Background | 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. |