Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Prasugrel Versus Clopidogrel to TREAT High Platelet Reactivity (TREAT-HPR)

This study has been completed.
Information provided by (Responsible Party):
Daniel Aradi MD, University of Pecs Identifier:
First received: December 14, 2011
Last updated: October 6, 2014
Last verified: October 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 Intervention Phase
Acute Coronary Syndrome
Drug: Clopidogrel reloading
Drug: Prasugrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University of Pecs:

Primary Outcome Measures:
  • ADP-reactivity between clopidogrel reloading and prasugrel arm [ Time Frame: 4 days after randomization ]
    Multiplate-assessed ADP-reactivity (area under curve, U)

Secondary Outcome Measures:
  • 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

Enrollment: 147
Study Start Date: September 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel arm
A loading dose of 60 mg prasugrel in patients with HPR after 600 mg clopidogrel.
Drug: Prasugrel
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


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01493999

University of Pécs, Heart Institute
Pécs, Hungary, 7624
Sponsors and Collaborators
University of Pecs
Principal Investigator: Dániel Aradi, MD PhD University of Pécs, Heart Institute, Hungary
Study Director: András Komócsi, MD PhD University of Pécs, Heart Institute, Hungary
  More Information

Responsible Party: Daniel Aradi MD, Assisstant Professor, University of Pecs Identifier: NCT01493999     History of Changes
Other Study ID Numbers: PECS-002
Study First Received: December 14, 2011
Last Updated: October 6, 2014

Keywords provided by University of Pecs:
loading dose
maintenance dose
stent thrombosis
platelet reactivity
Coronary intervention
stent implantation

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017