Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention

NCT04999293 | Completed

• 1 other identifier: PJ-KS-KY-2021-146
• Study Type: observational
• Target: 1,505
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Aggregation Inhibitors; Dual Anti-Platelet Therapy; Aged; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

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

  The primary safety endpoint

  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

  12 months

Secondary Outcomes (8)

• All-cause mortality

  12 months

• Myocardial infarction

  12 months

• Revascularization

  12 months

• Ischemic stroke

  12 months

• Incidence of BARC3 and 5 bleeding

  12 months

Study Arms (1)

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

Ticagrelor DRUG

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

The Elderly Undergoing Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, 116011, China

Location

Related Publications (5)

• 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.

  PMID: 11520521 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

• 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.

  PMID: 22991347 BACKGROUND

• 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.

  PMID: 32334703 BACKGROUND

• 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.

  PMID: 35400997 DERIVED

MeSH Terms

Interventions

Ticagrelor; Clopidogrel

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Shaoke Meng, MD

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 10, 2021
• Study Start: July 20, 2021
• Primary Completion: August 5, 2021
• Study Completion: August 6, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

CN (1)