Acute Coronary Syndrome Clinical Trial
— TREAT-HPROfficial title:
Prasugrel Versus Adjusted High-dose Clopidogrel to TREAT High On-clopidogrel Platelet Reactivity in Acute Coronary Syndrome Patients After PCI
Verified date | October 2014 |
Source | University of Pecs |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hungary: National Institute of Pharmacy |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 147 |
Est. completion date | April 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 74 Years |
Eligibility |
Inclusion Criteria: - Age between 18-74 years - PCI with stent implantation due to stable angina or acute coronary syndrome - Platelet function assessment available 6-24 hours after PCI - Multiplate-derived ADP-reactivity > 47 U Exclusion Criteria: - Age =75 years - Prior TIA or stroke - Body weight less than 60 kg - Contraindication for aspirin / thienopyridines - Severe liver failure (Child Pugh C) - Need for oral anticoagulation in the following one month - Planned discontinuation of antiplatelet treatment in one month - Current bleeding disorder, active bleeding event (Weber positivity) - Haemoglobin level at presentation < 90 g/l - Refused informed consent |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hungary | University of Pécs, Heart Institute | Pécs |
Lead Sponsor | Collaborator |
---|---|
University of Pecs |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ADP-reactivity between clopidogrel reloading and prasugrel arm | Multiplate-assessed ADP-reactivity (area under curve, U) | 4 days after randomization | No |
Secondary | The proportion of patients with HPR | Multiplate-assessed HPR > 47 U. | 4 days after randomization | No |
Secondary | ADP-reactivity between clopidogrel and prasugrel arms | Multiplate-assessed ADP-reactivity (are under curve, U) | 30 days after randomization | No |
Secondary | The proportion of patients with HPR between clopidogrel and prasugrel arms | Multiplate-assessed HPR >47 U. | 30 days after randomization | No |
Secondary | VASP-PRI between clopidogrel and prasugrel patients | Vasodilator stimulated phosphoprotein phosphorylation assessed with flow cytometer | 30 days after randomization | No |
Secondary | Cardiovascular death, myocardial infarction or definite/probable stent thrombosis | 30 days after randomization | No | |
Secondary | TIMI major bleeding | Thrombolysis in Myocardial Infarction-defined major bleeding complications | 30 days after randomization | Yes |
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