Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity (TREAT-HPR)
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|ClinicalTrials.gov Identifier: NCT01493999|
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : October 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Drug: Clopidogrel reloading Drug: Prasugrel||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prasugrel Versus Adjusted High-dose Clopidogrel to TREAT High On-clopidogrel Platelet Reactivity in Acute Coronary Syndrome Patients After PCI|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||April 2013|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|