Non-ST-elevation Acute Coronary Syndrome, Non-ST-elevation Myocardial Infarction, Unstable Angina
Conditions
Keywords
Elderly, P2Y12 inhibitors, clopidogrel, ticagrelor
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).
Interventions
DRUGClopidogrel
Sponsors
UMC Utrecht
Leiden University Medical Center
Meander Medical Center
Medical Center Alkmaar
Isala
Gelre Hospitals
Gelderse Vallei Hospital
Frisius Medisch Centrum
Rijnstate Hospital
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation | One year | — |
| net clinical benefit at 1 year after randomisation | One year | All cause mortality, non-fatal myocardial infarction, non-fatal stroke, PLATO major and minor bleeding |
Countries
Netherlands
Outcome results
None listed