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 range18 Years – 74 Years

SexALL

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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

What they're measuring

ADP-reactivity between clopidogrel reloading and prasugrel arm

Timeframe: 4 days after randomization

Trial details

NCT IDNCT01493999

SponsorUniversity of Pecs

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-01

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