Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity (NCT01493999) | Clinical Trial Compass
CompletedPhase 4
Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity
Hungary147 participantsStarted 2011-09
Plain-language summary
MAIN AIM: To compare the pharmacological potency of administering adjusted 600 mg clopidogrel loading doses and 60 mg prasugrel in patients with high on-clopidogrel platelet reactivity (HPR) after PCI.
SECONDARY OBJECTIVES: To define the optimal maintenance dose with both prasugrel (5 mg vs. 10 mg) and clopidogrel (75 mg vs. 150 mg) in patients with HPR for chronic therapy.
DESIGN: Prospective, Randomized, Open-label, Single-center trial.
PRIMARY ENDPOINT: Platelet reactivity measured with Multiplate between clopidogrel and prasugrel arm at day 4.
Who can participate
Age range
18 Years – 74 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:
* Age between 18-74 years
* PCI with stent implantation due to stable angina or acute coronary syndrome
* Platelet function assessment available 6-24 hours after PCI
* Multiplate-derived ADP-reactivity \> 47 U
Exclusion Criteria:
* Age ≥75 years
* Prior TIA or stroke
* Body weight less than 60 kg
* Contraindication for aspirin / thienopyridines
* Severe liver failure (Child Pugh C)
* Need for oral anticoagulation in the following one month
* Planned discontinuation of antiplatelet treatment in one month
* Current bleeding disorder, active bleeding event (Weber positivity)
* Haemoglobin level at presentation \< 90 g/l
* Refused informed consent
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
ADP-reactivity between clopidogrel reloading and prasugrel arm