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

NCT04861363 | Unknown DMC

• 1 other identifier: ESR-18-13975
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (3)

• Any cause death

  12 months

• Myocardial infarction

  12 months

• Stroke

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ACS patients taking ticagrelor 90 mg twice a day as part of the dual antiplatelet therapy at discharge

You may qualify if:

• ACS patients hospitalized during the following period: from January 2019 to September 2019
• Patients receiving ticagrelor as part of DAPT at hospital discharge.
• Patient enrolled into the follow-up program of ACS patients

You may not qualify if:

• Patients participated in other interventional clinical trials

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Division of Cardiology, Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (6)

• 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.

  PMID: 27595685 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.

  PMID: 28886622 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.

  PMID: 19717846 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.

  PMID: 28213881 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.

  PMID: 19954264 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.

  PMID: 18237359 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yong Huo, M.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Former director of the Department of cardiology, Principal Investigator, Clinical professor

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 27, 2021
• Study Start: June 19, 2019
• Primary Completion: July 19, 2021
• Study Completion: July 19, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)