Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome an… (NCT02317198) | Clinical Trial Compass
CompletedPhase 4
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
Netherlands1,011 participantsStarted 2013-06
Plain-language 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).
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
occurrence of any bleeding episode requiring medical intervention at 1 year after randomisation
Timeframe: One year
2
net clinical benefit at 1 year after randomisation