coronary artery disease
Conditions
Interventions
Patients randomized to clopidogrel will receive 75 mg daily for one year. Those
randomized to the new antiplatelet drugs will be treated with either ticagrelor
90 mg twice daily or prasugrel 10 mg d
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) At least 70 years of age. 2) Hospitalization for NSTEMI or unstable angina according to the criteria of the ESC guideline.
Exclusion criteria
Exclusion criteria: 1) Contraindication to P2Y12 inhibitors i.e. clopidogrel, prasugrel or ticagrelor: - Hypersensitivity to the active substance or to any of the excipients. - History of intracranial bleeding or active pathological bleeding such as peptic ulcer or intracranial haemorrhage. - Moderate to severe (Child-Pugh C) hepatic dysfunction. - Use of strong CYP3A4 inhibitors (i.e. itraconazole, voriconazole, ketoconazole, erytromycin, clarithromycin, rifampicin, nefozodone, lopinavir, carbamazepine, fenytoïne, fenobarbital, ritonavir en atazanavir). 2) Unable or unwilling to give informed consent or have a life expectancy of less than one year. 3) Having received thrombolytic therapy within the previous 24 hours. 4) Severe renal function impairment needing dialysis. 5) Confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization. 6) At increased bleeding risk, at the investigator*s opinion, i.e. because of malignancy. 7) Cardiogenic shock (SBP * 80mmHg for >30 mins) or Intra-Aortic Balloon Pump (IABP) at the time of screening. 8) History of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation. 9) Clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator*s opinion. 10) ACS under dual antiplatelet therapy, e.g. aspirin with a P2Y12 inhibitor; clopidogrel, prasugrel, ticagrelor. 11) Patients with a known CYP2C19 genotype at the time of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first primary endpoint is the occurrence of any bleeding episode at 1 year after randomisation and second primary endpoint is the net clinical benefit at 1 year after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary safety endpoints are bleeding events either CABG related or non-CABG related, according to TIMI (10), PLATO (2), GUSTO (11), and BARC (12) classification and composite of bleeding events within each classification at 30 days and 1 year after randomisation. Secondary net clinical benefit endpoints are composites of death from any cause other than vascular or bleeding causes, death from vascular causes, death from bleeding causes (= fatal bleeding), MI (13), stroke, UA, TIA, other arterial thrombosis, PLATO major and minor bleeding at 30 days and 1 year after randomisation. Secondary efficacy endpoints are death from any cause, death from cardiovascular causes, death from cerebrovascular causes MI (13), stent thrombosis as defined by ARC (14), UR, rehospitalization for ACS, stroke, TIA or composites of these endpoints at 30 days and 1 year after randomisation. Secondary endpoints in terms of quality of life are measurements obtained with EuroQol 5D and SF36 questionnaires and frailty by using the Groningen Frailty Indicator at one month and one year. A secondary endpoint is the number of patients in whom the antiplatelet drug is prematurely discontinued or switched to another drug leading to a cross-over. Tertiary endpoints would be the evaluation of genetic variants on the response to clopidogrel and prasugrel or ticagrelor in terms of efficacy and safety in a candidate gene approach, Genome Wide Association Study or (next generation) sequencing. Tertiary endpoint would be the evaluation of frailty according to the Groningen Frailty indicator (GFI * 4 would indicate a frail patient). | — |
Countries
Netherlands
Outcome results
None listed