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
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| Titel: | 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 |
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| Autoren: | Gimbel, Marieke, Qaderdan, Khalid, Willemsen, Laura, Hermanides, Rik, Bergmeijer, Thomas, de Vrey, Evelyn, Heestermans, Ton, Tjon Joe Gin, Melvyn, Waalewijn, Reinier, Hofma, Sjoerd, den Hartog, Frank, Jukema, Wouter, von Birgelen, Clemens, Voskuil, Michiel, Kelder, Johannes, Deneer, Vera, Ten Berg, Jurriën |
| Quelle: | The Lancet HIV vol.395 (2020) date: 2020-04-24 nr.10233 p.1374-1381 [ISSN 0140-6736] |
| Verlagsinformationen: | 2020 |
| Publikationsart: | Electronic Resource |
| Abstract: | BACKGROUND: Current guidelines recommend potent platelet inhibition with ticagrelor or prasugrel in patients after an acute coronary syndrome. However, data about optimal platelet inhibition in older patients are scarce. We aimed to investigate the safety and efficacy of clopidogrel compared with ticagrelor or prasugrel in older patients with non-ST-elevation acute coronary syndrome (NSTE-ACS).METHODS: We did the open-label, randomised controlled POPular AGE trial in 12 sites (ten hospitals and two university hospitals) in the Netherlands. Patients aged 70 years or older with NSTE-ACS were enrolled and randomly assigned in a 1:1 ratio using an internet-based randomisation procedure with block sizes of six to receive a loading dose of clopidogrel 300 mg or 600 mg, or ticagrelor 180 mg or prasugrel 60 mg, and then a maintenance dose for the duration of 12 months (clopidogrel 75 mg once daily, ticagrelor 90 mg twice daily, or prasugrel 10 mg once daily) on top of standard care. Patient and treating physicians were aware of the allocated treatment strategy, but the outcome assessors were masked to treatment allocation. Primary bleeding outcome consisted of PLATelet inhibition and patient Outcomes (PLATO; major or minor bleeding [superiority hypothesis]). Co-primary net clinical benefit outcome consisted of all-cause death, myocardial infarction, stroke, PLATO major and minor bleeding (non-inferiority hypothesis, margin of 2%). Follow-up duration was 12 months. Analyses were done on intention-to-treat basis. This trial is registered with the Netherlands Trial Register (NL3804), ClinicalTrials.gov (NCT02317198), and EudraCT (2013-001403-37).FINDINGS: Between June 10, 2013, and Oct 17, 2018, 1002 patients were randomly assigned to clopidogrel (n=500) or ticagrelor or prasugrel (n=502). Because 475 (95%) patients received ticagrelor in the ticagrelor or prasugrel group, we will refer to this group as the ticagrelor group. Premature discontinuation of the st |
| Index Begriffe: | Acute Coronary Syndrome/drug therapy, Aged, Aged, 80 and over, Clopidogrel/adverse effects, Female, Humans, Male, Myocardial Infarction/prevention & control, Platelet Aggregation Inhibitors/adverse effects, Prasugrel Hydrochloride/adverse effects, Stroke/prevention & control, Ticagrelor/adverse effects, Article |
| URL: | |
| Verfügbarkeit: | Open access content. Open access content info:eu-repo/semantics/openAccess |
| Anmerkung: | DOI: 10.1016/S0140-6736(20)30325-1 English |
| Other Numbers: | QGJ oai:research-portal.uu.nl:publications/56ee5aea-ea09-4c92-a769-8c522430317e 1445815114 |
| Originalquelle: | UNIVERSITEIT UTRECHT From OAIster®, provided by the OCLC Cooperative. |
| Dokumentencode: | edsoai.on1445815114 |
| Datenbank: | OAIster |
Nájsť tento článok vo Web of Science | Abstract: | BACKGROUND: Current guidelines recommend potent platelet inhibition with ticagrelor or prasugrel in patients after an acute coronary syndrome. However, data about optimal platelet inhibition in older patients are scarce. We aimed to investigate the safety and efficacy of clopidogrel compared with ticagrelor or prasugrel in older patients with non-ST-elevation acute coronary syndrome (NSTE-ACS).METHODS: We did the open-label, randomised controlled POPular AGE trial in 12 sites (ten hospitals and two university hospitals) in the Netherlands. Patients aged 70 years or older with NSTE-ACS were enrolled and randomly assigned in a 1:1 ratio using an internet-based randomisation procedure with block sizes of six to receive a loading dose of clopidogrel 300 mg or 600 mg, or ticagrelor 180 mg or prasugrel 60 mg, and then a maintenance dose for the duration of 12 months (clopidogrel 75 mg once daily, ticagrelor 90 mg twice daily, or prasugrel 10 mg once daily) on top of standard care. Patient and treating physicians were aware of the allocated treatment strategy, but the outcome assessors were masked to treatment allocation. Primary bleeding outcome consisted of PLATelet inhibition and patient Outcomes (PLATO; major or minor bleeding [superiority hypothesis]). Co-primary net clinical benefit outcome consisted of all-cause death, myocardial infarction, stroke, PLATO major and minor bleeding (non-inferiority hypothesis, margin of 2%). Follow-up duration was 12 months. Analyses were done on intention-to-treat basis. This trial is registered with the Netherlands Trial Register (NL3804), ClinicalTrials.gov (NCT02317198), and EudraCT (2013-001403-37).FINDINGS: Between June 10, 2013, and Oct 17, 2018, 1002 patients were randomly assigned to clopidogrel (n=500) or ticagrelor or prasugrel (n=502). Because 475 (95%) patients received ticagrelor in the ticagrelor or prasugrel group, we will refer to this group as the ticagrelor group. Premature discontinuation of the st |
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