Acute Coronary SyndromeNCT04861363
Follow up of Ticagrelor Treatment Patterns in Chinese Acute Coronary Syndromes Patients
An observational study of Acute Coronary Syndrome, run by Peking University First Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2019to 19 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ACS patients taking ticagrelor 90 mg twice a day as part of the dual antiplatelet therapy at discharge
Who may be able to join
- 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
Who cannot join
- Patients participated in other interventional clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Cardiology, Peking University First Hospital
Beijing, 100034
About this study
Official title: Follow up of Ticagrelor Treatment Patterns in Chinese Acute Coronary Syndromes Patients- A Database Retrospective Study
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.
Read the detailed 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:
- To describe the ticagrelor treatment patterns-Ticagrelor persistence, discontinuation, switching, interruption and reasons for discontinuation/switching/interruption in Chinese ACS patients.
- 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:
- 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.)
- 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:
- Ticagrelor treatment patterns-Ticagrelor persistence, discontinuation, switch, interruption and reasons for switching/discontinuation/interruption
- Ticagrelor persistence: Proportion of patients who is on ticagrelor treatment every month after discharge; Duration of time from initiation to discontinuation of therapy.
- 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:
- Time to the first occurrence of each component of primary clinical events (any cause death, myocardial infarction, Stroke) in the first year after discharge.
- Proportion of ticagrelor treatment patterns with different clinical outcomes
- 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:
- Ticagrelor treatment patterns -Persistence, discontinuation rate, switching and interruption in Chinese ACS patients after hospital discharge;
- 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.
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 12 months
Major Adverse Cardiovascular Events
Time to the first occurence of Any cause death, myocardial infarction, or Stroke
Measured: 12 months
Secondary outcomes (3)
Any cause death
Time to the occurence of Any cause death
Measured: 12 months
Myocardial infarction
Time to the first occurence of Myocardial infarction
Measured: 12 months
Stroke
Time to the first occurence of Stroke
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start19 Jun 2019
- Primary completion19 Jul 2021 (estimated)
- Study completion19 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
- Investigators
- Yong Huo, M.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861363
- Sponsor's protocol ID
- ESR-18-13975
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27595685Valgimigli 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.
PubMed 28886622Wallentin 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.
PubMed 19717846Sun 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.
PubMed 28213881Yeaw 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.
PubMed 19954264Cramer 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.
PubMed 18237359
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Ticagrelor Treatment Patterns in Chinese Acute Coronary Syndromes Patients- A Database Retrospective Study
- ClinicalTrials.gov ID
- NCT04861363
- Acronym / sponsor ID
- ESR-18-13975
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 19 Jul 2021 (estimated)
- Study completion
- 19 Jul 2021 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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:
- To describe the ticagrelor treatment patterns-Ticagrelor persistence, discontinuation, switching, interruption and reasons for discontinuation/switching/interruption in Chinese ACS patients.
- 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:
- 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.)
- 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:
- Ticagrelor treatment patterns-Ticagrelor persistence, discontinuation, switch, interruption and reasons for switching/discontinuation/interruption
- Ticagrelor persistence: Proportion of patients who is on ticagrelor treatment every month after discharge; Duration of time from initiation to discontinuation of therapy.
- 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:
- Time to the first occurrence of each component of primary clinical events (any cause death, myocardial infarction, Stroke) in the first year after discharge.
- Proportion of ticagrelor treatment patterns with different clinical outcomes
- 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:
- Ticagrelor treatment patterns -Persistence, discontinuation rate, switching and interruption in Chinese ACS patients after hospital discharge;
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ACS patients taking ticagrelor 90 mg twice a day as part of the dual antiplatelet therapy at discharge
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients participated in other interventional clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ticagrelor persistence
Time frame: 12 months
Duration of ticagrelor treatment: Proportion of patients receiving ticagrelor each month after discharge; Duration from the start of treatment to the end of treatment.
Ticagrelor discontinuation and reasons for discontinuation
Time frame: 12 months
Percentage of patients with ticagrelor discontinuation and related causes: Discontinuation was defined as stopping P2Y12 for at least 3 months.
Ticagrelor switch and reasons for switching
Time frame: 12 months
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)
Ticagrelor interruption and reasons for interruption
Time frame: 12 months
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.
Major Adverse Cardiovascular Events
Time frame: 12 months
Time to the first occurence of Any cause death, myocardial infarction, or Stroke
3 secondary outcomes
Any cause death
Time frame: 12 months
Myocardial infarction
Time frame: 12 months
Stroke
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 27595685Hao 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.
- Background: PubMed 28886622Valgimigli 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.
- Background: PubMed 19717846Wallentin 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.
- Background: PubMed 28213881Sun 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.
- Background: PubMed 19954264Yeaw 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.
- Background: PubMed 18237359Cramer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Huo, M.D. principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ticagrelor persistence (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04861363, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.