Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity (TREAT-HPR)
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.
|Acute Coronary Syndrome||Drug: Clopidogrel reloading Drug: Prasugrel||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Prasugrel Versus Adjusted High-dose Clopidogrel to TREAT High On-clopidogrel Platelet Reactivity in Acute Coronary Syndrome Patients After PCI|
- ADP-reactivity between clopidogrel reloading and prasugrel arm [ Time Frame: 4 days after randomization ]Multiplate-assessed ADP-reactivity (area under curve, U)
- The proportion of patients with HPR [ Time Frame: 4 days after randomization ]Multiplate-assessed HPR > 47 U.
- ADP-reactivity between clopidogrel and prasugrel arms [ Time Frame: 30 days after randomization ]Multiplate-assessed ADP-reactivity (are under curve, U)
- The proportion of patients with HPR between clopidogrel and prasugrel arms [ Time Frame: 30 days after randomization ]Multiplate-assessed HPR >47 U.
- VASP-PRI between clopidogrel and prasugrel patients [ Time Frame: 30 days after randomization ]Vasodilator stimulated phosphoprotein phosphorylation assessed with flow cytometer
- Cardiovascular death, myocardial infarction or definite/probable stent thrombosis [ Time Frame: 30 days after randomization ]
- TIMI major bleeding [ Time Frame: 30 days after randomization ]Thrombolysis in Myocardial Infarction-defined major bleeding complications
|Study Start Date:||September 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Prasugrel arm
A loading dose of 60 mg prasugrel in patients with HPR after 600 mg clopidogrel.
60 mg prasugrel in patients with HPR
Other Name: Prasugrel = EFIENT
Active Comparator: Clopidogrel reloading
A maximum of three adjusted loading doses of 600 mg clopidogrel until normal platelet reactivity is achieved in patients with HPR after the first 600 mg clopidogrel.
Drug: Clopidogrel reloading
Up to three times 600 mg clopidogrel
Other Name: Clopidogrel = KARDOGREL
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493999
|University of Pécs, Heart Institute|
|Pécs, Hungary, 7624|
|Principal Investigator:||Dániel Aradi, MD PhD||University of Pécs, Heart Institute, Hungary|
|Study Director:||András Komócsi, MD PhD||University of Pécs, Heart Institute, Hungary|