Platelet Aggregation InhibitorsNCT04999293
Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention
An observational study of Platelet Aggregation Inhibitors and Dual Anti-Platelet Therapy, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
The study is an investigator-sponsored, retrospective cohort study designed to compare efficacy and safety of ticagrelor in elderly patients undergoing percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Platelet Aggregation Inhibitors, Dual Anti-Platelet Therapy, Aged
- What is being tested?
- Ticagrelor
- How many people
- 1,505 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to 6 Aug 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients ≥75 years of age who were treated with PCI (limited to stent implantation) at the First Affiliated Hospital of Dalian Medical University from January 1, 2015 to December 31, 2019 were screened for additional enrollment criteria.
Who may be able to join
- Age≥75 years old;
- Treated with PCI (limited to stent implantation) ;
- Survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at discharge;
Who cannot join
- Coronary artery bypass graft (CABG) or only drug conservative treatment during hospitalization;
- Concurrent use of oral anticoagulants;
- Inability to tolerate long-term antiplatelet therapy, such as active bleeding and a bleeding tendency;
- Acute infectious diseases;
- Cognitive impairment;
- Declined re-examination.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Dalian Medical University
Dalian, 116011
About this study
Official title: Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention
The study is an investigator-sponsored, retrospective cohort study designed to compare efficacy and safety of ticagrelor in elderly patients undergoing percutaneous coronary intervention.
- Conditions
- Platelet Aggregation Inhibitors, Dual Anti-Platelet Therapy, Aged, Percutaneous Coronary Intervention
- Being tested
- Ticagrelor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Clopidogrel
Patients were survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| The Elderly Undergoing Percutaneous Coronary Intervention | Patients were survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge. Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium
The primary safety endpoint
Measured: 12 months
Combined major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause mortality, myocardial infarction, ischemic stroke, and any revascularization.
The primary efficacy endpoint
Measured: 12 months
Secondary outcomes (8)
All-cause mortality
Measured: 12 months
Myocardial infarction
Measured: 12 months
Revascularization
Measured: 12 months
Ischemic stroke
Measured: 12 months
Incidence of BARC3 and 5 bleeding
Measured: 12 months
Incidence of major and minor bleeding defined by the PLATO study
Measured: 12 months
Incidence of major and minor bleeding defined by the TIMI study
Measured: 12 months
Occurrence of any bleeding
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 posted10 Aug 2021
- Study start20 Jul 2021
- Primary completion5 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Platelet Aggregation InhibitorsStudies of the same condition, open and under way.
- 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
- 1,505 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Shaoke, The First Affiliated Hospital of Dalian Medical University
- Investigators
- Shaoke Meng, MD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999293
- Sponsor's protocol ID
- PJ-KS-KY-2021-146
- Status last verified
- Aug 2021
- First submitted
- 5 Aug 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4.
PubMed 11520521Wallentin 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 19717846Husted S, James S, Becker RC, Horrow J, Katus H, Storey RF, Cannon CP, Heras M, Lopes RD, Morais J, Mahaffey KW, Bach RG, Wojdyla D, Wallentin L; PLATO study group. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet inhibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):680-8. doi: 10.1161/CIRCOUTCOMES.111.964395.
PubMed 22991347Gimbel M, Qaderdan K, Willemsen L, Hermanides R, Bergmeijer T, de Vrey E, Heestermans T, Tjon Joe Gin M, Waalewijn R, Hofma S, den Hartog F, Jukema W, von Birgelen C, Voskuil M, Kelder J, Deneer V, Ten Berg J. Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial. Lancet. 2020 Apr 25;395(10233):1374-1381. doi: 10.1016/S0140-6736(20)30325-1.
PubMed 32334703Meng S, Guo L, Ye Z, Wang J, Ding H, Wu S, Huang R. Comparison of Clinical Outcomes Between Ticagrelor and Clopidogrel in Elderly Patients Undergoing Percutaneous Coronary Intervention: A Cohort Study. Clin Interv Aging. 2022 Apr 2;17:331-341. doi: 10.2147/CIA.S355210. eCollection 2022.
PubMed 35400997
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04999293
- Acronym / sponsor ID
- PJ-KS-KY-2021-146
- Conditions
- Platelet Aggregation Inhibitors, Dual Anti-Platelet Therapy, Aged, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,505 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 10 Aug 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.
The study is an investigator-sponsored, retrospective cohort study designed to compare efficacy and safety of ticagrelor in elderly patients undergoing percutaneous coronary intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Elderly Undergoing Percutaneous Coronary Intervention | – | Drug: TicagrelorPatients were survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients ≥75 years of age who were treated with PCI (limited to stent implantation) at the First Affiliated Hospital of Dalian Medical University from January 1, 2015 to December 31, 2019 were screened for additional enrollment criteria.
Key inclusion criteria (3 listed)
- Age≥75 years old;
- Treated with PCI (limited to stent implantation) ;
- Survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at discharge;
Key exclusion criteria (6 listed)
- Coronary artery bypass graft (CABG) or only drug conservative treatment during hospitalization;
- Concurrent use of oral anticoagulants;
- Inability to tolerate long-term antiplatelet therapy, such as active bleeding and a bleeding tendency;
- Acute infectious diseases;
- Cognitive impairment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: ClopidogrelPatients were survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge. | Drug | The Elderly Undergoing Percutaneous Coronary Intervention |
Primary outcome
Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium
Time frame: 12 months
The primary safety endpoint
Combined major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause mortality, myocardial infarction, ischemic stroke, and any revascularization.
Time frame: 12 months
The primary efficacy endpoint
8 secondary outcomes
All-cause mortality
Time frame: 12 months
Myocardial infarction
Time frame: 12 months
Revascularization
Time frame: 12 months
Ischemic stroke
Time frame: 12 months
Incidence of BARC3 and 5 bleeding
Time frame: 12 months
Incidence of major and minor bleeding defined by the PLATO study
Time frame: 12 months
Incidence of major and minor bleeding defined by the TIMI study
Time frame: 12 months
Occurrence of any bleeding
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Background: PubMed 11520521Mehta SR, Yusuf S, Peters RJ, Bertrand ME, Lewis BS, Natarajan MK, Malmberg K, Rupprecht H, Zhao F, Chrolavicius S, Copland I, Fox KA; Clopidogrel in Unstable angina to prevent Recurrent Events trial (CURE) Investigators. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001 Aug 18;358(9281):527-33. doi: 10.1016/s0140-6736(01)05701-4.
- 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 22991347Husted S, James S, Becker RC, Horrow J, Katus H, Storey RF, Cannon CP, Heras M, Lopes RD, Morais J, Mahaffey KW, Bach RG, Wojdyla D, Wallentin L; PLATO study group. Ticagrelor versus clopidogrel in elderly patients with acute coronary syndromes: a substudy from the prospective randomized PLATelet inhibition and patient Outcomes (PLATO) trial. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):680-8. doi: 10.1161/CIRCOUTCOMES.111.964395.
- Background: PubMed 32334703Gimbel M, Qaderdan K, Willemsen L, Hermanides R, Bergmeijer T, de Vrey E, Heestermans T, Tjon Joe Gin M, Waalewijn R, Hofma S, den Hartog F, Jukema W, von Birgelen C, Voskuil M, Kelder J, Deneer V, Ten Berg J. Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial. Lancet. 2020 Apr 25;395(10233):1374-1381. doi: 10.1016/S0140-6736(20)30325-1.
- Derived from this study: PubMed 35400997Meng S, Guo L, Ye Z, Wang J, Ding H, Wu S, Huang R. Comparison of Clinical Outcomes Between Ticagrelor and Clopidogrel in Elderly Patients Undergoing Percutaneous Coronary Intervention: A Cohort Study. Clin Interv Aging. 2022 Apr 2;17:331-341. doi: 10.2147/CIA.S355210. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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.
Shaoke Meng, MD principal investigator
The First Affiliated Hospital of Dalian Medical University
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 Platelet Aggregation Inhibitors and Dual Anti-Platelet Therapy, run by The First Affiliated Hospital of Dalian Medical University 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 6 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: finished, as of the sponsor's last update on 10 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium (time frame: 12 months). The study lists 2 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 NCT04999293, which also lists 5 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 10 Aug 2021.