Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing

• Status: Unknown status
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Clopidogrel low response is associated with a significantly higher risk for ischemic complications after percutaneous coronary intervention. Ticagrelor and prasugrel are more potent platelet inhibitory drugs and both have been shown to significantly reduce ischemic events as compared to clopidogrel. No direct comparison between ticagrelor and prasugrel in terms of their antiplatelet efficacy exists. The aim of this study is to assess the antiplatelet treatment efficacy of ticagrelor versus prasugrel over time in confirmed clopidogrel low responders undergoing percutaneous coronary intervention.

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

Details

• Lead Sponsor: Deutsches Herzzentrum Muenchen
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

• successful PCI

• 600 mg clopidogrel pretreatment

• clopidogrel low response assessed with electrode aggregometry (>= 486 AU*min)

• written informed consent

Exclusion Criteria:

• Contraindications or allergies against study drugs

• Anemia

• Any surgery < 6 weeks

• Increased bleeding risk

• Oral anticoagulation

• platelet count < 100.000/µl

• Prior history of stroke or pathologic intracranial findings

• GPIIb/IIIa antagonists < 10 days or periprocedural

• Age > 80 years, < 18 years

• Body weight < 60 kg

• Cardiogenic shock

• Increased risk of bradycardia

• Moderate liver disease

• Kidney dialysis

• Intake of CYP 3A4 inhibitors

• Pregnancy or lactation

• Missing pregnancy test for women capable of bearing children