Clinical trial NCT04999293: Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention
Official title: Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Aggregation Inhibitors
Dual Anti-Platelet Therapy
Aged
Percutaneous Coronary Intervention
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 1505
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium
timeFrame: 12 months
measure: Combined major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause mortality, myocardial infarction, ischemic stroke, and any revascularization.
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Revascularization
timeFrame: 12 months
measure: Ischemic stroke
timeFrame: 12 months
measure: Incidence of BARC3 and 5 bleeding
timeFrame: 12 months
measure: Incidence of major and minor bleeding defined by the PLATO study
timeFrame: 12 months
measure: Incidence of major and minor bleeding defined by the TIMI study
timeFrame: 12 months
measure: Occurrence of any bleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Shaoke Meng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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, 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.
citation: Husted 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.
citation: Gimbel 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.
citation: Meng 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.