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

Phase 4

• Conditions: Coronary Heart Disease
• Interventions: Drug: Prasugrel; Drug: Ticagrelor

• Registration Number: NCT01456364
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01
• Primary Completion: 2014-04
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel	Prasugrel	A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients \< 75 years or a 5 mg maintenance dose per day for patients \>= 75 years
Ticagrelor	Ticagrelor	A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily

Primary Outcome Measures

Name	Time	Method
ADP-induced platelet aggregation after randomized treatment with ticagrelor or prasugrel	Day 2 post randomization

Secondary Outcome Measures

Name	Time	Method
Proportion of low responders in ticagrelor or prasugrel group	Day 2 post randomization	Low platelet response is defined as platelet aggregation values \>=468 AU\*min
Proportion of enhanced responders in ticagrelor or prasugrel group	Day 2 post randomization	Enhanced platelet response is defined as platelet aggregation values \<= 188 AU\*min

Trial Locations

Locations (3)

Deutsches Herzzentrum; 🇩🇪 München, Bavaria, Germany

Klinikum der Ludwig-Maximilians-Universität München; 🇩🇪 München, Bavaria, Germany

Heart Center Balatonfüred, Dept. of Cardiology; 🇭🇺 Balatonfüred, Hungary