Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pecs
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

Criteria

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