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
POPular AGE
1 other identifier
interventional
1,011
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
December 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedMay 30, 2024
May 1, 2024
5.4 years
October 10, 2014
May 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
One year
net clinical benefit at 1 year after randomisation
All cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding
One year
Study Arms (2)
Intervention
EXPERIMENTALClopidogrel
Control
ACTIVE COMPARATORTicagrelor/Prasugrel
Interventions
Eligibility Criteria
You may qualify if:
- At least 70 years of age.
- Hospitalization for NSTEMI or UA \< 72 hours
You may not qualify if:
- Contraindication to P2Y12 inhibitors i.e. clopidogrel, prasugrel or ticagrelor:
- Unable or unwilling to give informed consent or have a life expectancy of less than one year.
- Having received thrombolytic therapy within the previous 24 hours.
- Severe renal function impairment needing dialysis.
- Confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) \> 180 mmHg and/or Diastolic Blood Pressure (DBP) \>110 mmHg) at randomization.
- At increased bleeding risk, at the investigator's opinion, e.g. because of malignancy.
- Cardiogenic shock (SBP ≤ 80mmHg for \>30 mins) or Intra-Aortic Balloon Pump (IABP) at the time of screening.
- History of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation.
- Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator's opinion.
- ACS under dual antiplatelet therapy, e.g. aspirin with a P2Y12 inhibitor; clopidogrel, prasugrel, ticagrelor.
- Patients with a known CYP2C19 genotype at the time of randomization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Antonius Hospitallead
- UMC Utrechtcollaborator
- Leiden University Medical Centercollaborator
- Meander Medical Centercollaborator
- Medical Center Alkmaarcollaborator
- Isalacollaborator
- Gelre Hospitalscollaborator
- Gelderse Vallei Hospitalcollaborator
- Frisius Medisch Centrumcollaborator
- Rijnstate Hospitalcollaborator
Study Sites (1)
St. Antonius hospital
Nieuwegein, Utrecht, 3430 EM, Netherlands
Related Publications (3)
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.
PMID: 35723240DERIVEDGimbel 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: 32334703DERIVEDQaderdan 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.
PMID: 26542508DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jurriën M ten Berg, MD, PhD
St. Antonius Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 10, 2014
First Posted
December 15, 2014
Study Start
June 1, 2013
Primary Completion
November 1, 2018
Study Completion
November 1, 2019
Last Updated
May 30, 2024
Record last verified: 2024-05