Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing (ISAR ADAPT PF)

German Heart Center Munich

Status and phase: Unknown; Phase 4

Conditions: Coronary Heart Disease

Treatments: Drug: Ticagrelor; Drug: Prasugrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01456364

GE-DHM A01811

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Ticagrelor

Active Comparator group

Description:

A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily

Treatment:

Drug: Ticagrelor

Prasugrel

Active Comparator group

Description:

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

Treatment:

Drug: Prasugrel