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
- Conditions
- coronary artery disease10011082
- Registration Number
- NL-OMON47836
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1000
1) At least 70 years of age.
2) Hospitalization for NSTEMI or unstable angina according to the criteria of the ESC guideline.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The first primary endpoint is the occurrence of any bleeding episode at 1 year<br /><br>after randomisation and second primary endpoint is the net clinical benefit at<br /><br>1 year after randomisation.</p><br>
- Secondary Outcome Measures
Name Time Method