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CompletedNCT04999293Updated Aug 10, 2021

Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention

An observational study in Platelet Aggregation Inhibitors, Dual Anti-Platelet Therapy and Aged, sponsored by The First Affiliated Hospital of Dalian Medical University. Completed at 1 site in China. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2021-08-10.

Sponsored by The First Affiliated Hospital of Dalian Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,505
Ages
75 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Platelet Aggregation Inhibitors
  • Dual Anti-Platelet Therapy
  • Aged
  • Percutaneous Coronary Intervention
03

In context

Lead sponsor

The First Affiliated Hospital of Dalian Medical University is the lead sponsor of 41 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,505 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: Ticagrelor

Interventions

  • DrugTicagrelor

    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.

    Also known as: Clopidogrel

06

What researchers measure

Primary outcomes

  1. Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium

    The primary safety endpoint

    Time frame: 12 months

  2. Combined major adverse cardiovascular and cerebrovascular events (MACCEs), including all-cause mortality, myocardial infarction, ischemic stroke, and any revascularization.

    The primary efficacy endpoint

    Time frame: 12 months

Secondary outcomes

  1. All-cause mortality

    Time frame: 12 months

  2. Myocardial infarction

    Time frame: 12 months

  3. Revascularization

    Time frame: 12 months

  4. Ischemic stroke

    Time frame: 12 months

  5. Incidence of BARC3 and 5 bleeding

    Time frame: 12 months

  6. Incidence of major and minor bleeding defined by the PLATO study

    Time frame: 12 months

  7. Incidence of major and minor bleeding defined by the TIMI study

    Time frame: 12 months

  8. Occurrence of any bleeding

    Time frame: 12 months

07

Study locations

1 site
  • The First Affiliated Hospital of Dalian Medical University
    Dalian, 116011, China
08

References and documents

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 11520521 ↗
  • 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. PubMed 19717846 ↗
  • 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. PubMed 22991347 ↗
  • 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. PubMed 32334703 ↗
  • 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. PubMed 35400997 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04999293
Lead sponsor
The First Affiliated Hospital of Dalian Medical University
Responsible party
Meng Shaoke (M.D., The First Affiliated Hospital of Dalian Medical University) — Principal investigator
First posted
Aug 10, 2021
Start date
Jul 20, 2021
Primary completion
Aug 5, 2021
Completion
Aug 6, 2021
Last update
Aug 10, 2021

Study contacts

Shaoke Meng, MD
principal investigator · The First Affiliated Hospital of Dalian Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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