NCT01959451

Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial

Platelet Function Guided Prasugrel Therapy in ACS Patients Undergoing PCI

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,600 (actual)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study investigates whether a platelet function testing guided approach with a short-term (1 week) prasugrel treatment and a switch over to clopidogrel treatment in adequate responders to clopidogrel is non-inferior regarding the combined incidence of bleeding and thrombotic complications to a 12 month standard treatment with prasugrel in acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).

Detailed description

Patients suffering of heart attack have highly activated blood platelets. During and after invasive treatment of blocked coronary vessels (percutaneous coronary intervention = PCI) a potent platelet inhibition is needed to reduce the risk of thrombotic complications which is particularly high within the first week after PCI. On the other hand, the use of potent platelet inhibitors such as prasugrel is associated with higher bleeding risk particularly when used at long-term. A combination of a potent antiplatelet drug (prasugrel) within the first week with a less potent antiplatelet drug (clopidogrel) thereafter might lead to a higher net clinical benefit - means less bleeding and thrombotic complications. This hypothesis is being investigated in the current trial.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	Prasugrel	see Arm description
DRUG	Clopidogrel	see arm description

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-05-01
• Completion: 2017-06-01
• First posted: 2013-10-10
• Last updated: 2019-03-01

Locations

33 sites across 4 countries: Austria, Germany, Hungary, Poland