Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention

Percutaneous Coronary Intervention Clinical Trial

Official title:

Antiplatelet Therapy in Elderly Patients Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04999293
• Other study ID #: PJ-KS-KY-2021-146
• Status: Completed
• Start date: July 20, 2021
• Est. completion date: August 6, 2021

Study information

• Verified date: August 2021
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1505
• Est. completion date: August 6, 2021
• Est. primary completion date: August 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ticagrelor
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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, Thorsén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Types 2, 3, and 5 bleeding, as defined by the Bleeding Academic Research Consortium	The primary safety endpoint	12 months
Primary	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	All-cause mortality		12 months
Secondary	Myocardial infarction		12 months
Secondary	Revascularization		12 months
Secondary	Ischemic stroke		12 months
Secondary	Incidence of BARC3 and 5 bleeding		12 months
Secondary	Incidence of major and minor bleeding defined by the PLATO study		12 months
Secondary	Incidence of major and minor bleeding defined by the TIMI study		12 months
Secondary	Occurrence of any bleeding		12 months