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

St. Antonius Hospital0 个研究点开始时间: 2013年7月25日最近更新: 2013年8月19日

适应症

试验速览

暂无简介。

•1) At least 75 years of age.
•2) Hospitalization for NSTEMI or unstable angina (UAP), according to the following definitions
•NSTEMI (Non-ST-elevation myocardial infarction) will be defined as detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:
•- Symptoms of ischaemia.
•- New or presumed new significant ST-segment–T wave (ST–T) changes other than ST-segment elevation
•- Development of pathological Q waves in the ECG.
•- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
•- Identification of an intracoronary thrombus by angiography or autopsy
•UA (unstable angina) will be defined as acute onset of chest pain consistent with symptoms of ischaemia without rise in cardiac biomarker values, which may or may not be consistent with ECG changes suggesting ischaemia.
•Diagnosis of UA and NSTEMI are according to ESC guidelines.
•3) A CRUSADE bleeding risk score of at least 31.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1000

•1) allergy to P2Y12 inhibitors i.e. clopidogrel, prasugrel or ticagrelor
•2) unable or unwilling to give informed consent or have a life expectancy of less than one year
•3) active malignancy with increase in bleeding risk, in the investigator’s opinion
•4) having received thrombolytic therapy within the previous 24 hours or oral anticoagulants during the previous 7 days
•5) severe renal function impairment needing dialysis
•6) confirmed or persistent severe hypertension (Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) >110 mmHg) at randomization
•7) contraindication to anticoagulation or at increased bleeding risk, at the investigator’s opinion, i.e. because of active malignancy.
•8) cardiogenic shock (SBP = 80mmHg for >30 mins) or needing Intra-Aortic Balloon Pump (IABP) at presentation
•9) history of major surgery, severe trauma, fracture or organ biopsy within 90 days prior to randomisation
•10) clinically significant out of range values for platelet count or haemoglobin at screening, in the investigator’s opinion.
•11) ACS under dual antiplatelet therapy, e.g. aspirin with a P2Y12 inhibitor; clopidogrel, prasugrel, ticagrelor
•12) Patients either homozygous or heterozygous cariers of a non-functional CYP2C19*2 or *3 allele if known at time of randomization

发起方