Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly
Summary
A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and older, presenting with Non-ST-elevation acute coronary syndrome. Patients will be randomized to either clopidogrel or the novel P2Y12 inhibitor (ticagrelor or prasugrel). Patients will be followed for one year for outcomes such as bleeding episode requiring medical intervention and net clinical benefit (all cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding).
Timeline
- Start
- 2013-06
- Primary completion
- 2018-11
- Completion
- 2019-11
Outcome
Met primary endpoint
paper Primary bleeding outcome was significantly lower in the clopidogrel group (88 [18%] of 500 patients) than in the ticagrelor group (118 [24%] PMID 32334703 ↗
paper hazard ratio 0·71, 95% CI 0·54 to 0·94; p=0·02 for superiority). PMID 32334703 ↗
paper Co-primary net clinical benefit outcome was non-inferior for the use of clopidogrel PMID 32334703 ↗
paper 139 [28%]) versus ticagrelor (161 [32%]; absolute risk difference -4%, 95% CI -10·0 to 1·4; p=0·03 for non-inferiority). PMID 32334703 ↗
Publications
- van den Broek WWA, Gimbel ME, Hermanides RS, Runnett C, Storey RF, Knaapen P, Emans ME, Oemrawsingh RM, Cooke J, Galasko G, Walhout R, Stoel MG, von Birgelen C, van Bergen PFMM, Brinckman SL, Aksoy I, Liem A, Van't Hof AWJ, Jukema JW, Heestermans AACM, Nicastia D, Alber H, Austin D, Nasser A, Deneer V, Ten Berg JM. The impact of patient-reported frailty on cardiovascular outcomes in elderly patients after non-ST-acute coronary syndrome. Int J Cardiol. 2024 Jun 15;405:131940. doi: 10.1016/j.ijcard.2024.131940. Epub 2024 Mar 7.
- van den Broek WWA, van Paassen JG, Gimbel ME, Deneer VHM, Ten Berg JM, Vreman RA. Cost-effectiveness of clopidogrel vs. ticagrelor in patients of 70 years or older with non-ST-elevation acute coronary syndrome. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 15;9(1):76-84. doi: 10.1093/ehjcvp/pvac037.
- 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.
- Qaderdan K, Ishak M, Heestermans AA, de Vrey E, Jukema JW, Voskuil M, de Boer MJ, van't Hof AW, Groenemeijer BE, Vos GJ, Janssen PW, Bergmeijer TO, Kelder JC, Deneer VH, ten Berg JM. Ticagrelor or prasugrel versus clopidogrel in elderly patients with an acute coronary syndrome: Optimization of antiplatelet treatment in patients 70 years and older--rationale and design of the POPular AGE study. Am Heart J. 2015 Nov;170(5):981-985.e1. doi: 10.1016/j.ahj.2015.07.030. Epub 2015 Aug 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clopidogrel | Small molecule | 75 mg | — |
| Comparator | Prasugrel | Small molecule | 10 mg | — |
| Comparator | Ticagrelor | Small molecule | 90 mg | — |