Clinical trial NCT02317198: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-ST-elevation Acute Coronary Syndrome
Unstable Angina
Non-ST-elevation Myocardial Infarction
Keywords: Elderly
P2Y12 inhibitors
clopidogrel
ticagrelor
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Leiden University Medical Center
name: Meander Medical Center
name: Medical Center Alkmaar
name: Isala
name: Gelre Hospitals
name: Gelderse Vallei Hospital
name: Frisius Medisch Centrum
name: Rijnstate Hospital
First posted: 2014-12-15
Enrollment: 1011
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* At least 70 years of age.
* Hospitalization for NSTEMI or UA \< 72 hours

Exclusion Criteria:

* 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.

Primary outcomes:
measure: occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
timeFrame: One year
measure: net clinical benefit at 1 year after randomisation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St. Antonius hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Jurriën M ten Berg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.