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Prasugrel Antiplatelet Efficacy Compared to Clopidogrel adjuSted Loading Doses in Patients With High Platelet Reactivity After Stenting (PECS-HPR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Aradi MD, University of Pecs
ClinicalTrials.gov Identifier:
NCT01493999
First received: December 14, 2011
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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
High Platelet Reactivity (HPR)
 Drug: Clopidogrel reloading
Drug: Prasugrel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prasugrel Antiplatelet Efficacy Compared to Clopidogrel adjuSted Loading Doses in Patients With High Platelet Reactivity After Stenting

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    Multiplate-assessed ADP-reactivity (area under curve, U)


Secondary Outcome Measures:
  • The proportion of patients with HPR [ Time Frame: 4 days after randomization ] [ Designated as safety issue: No ]
    Multiplate-assessed HPR > 47 U.

  • ADP-reactivity between clopidogrel and prasugrel arms [ Time Frame: 30 days after randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Multiplate-assessed HPR >47 U.

  • VASP-PRI between clopidogrel and prasugrel patients [ Time Frame: 30 days after randomization ] [ Designated as safety issue: No ]
    Vasodilator stimulated phosphoprotein phosphorylation assessed with flow cytometer

  • Cardiovascular death, myocardial infarction or definite/probable stent thrombosis [ Time Frame: 30 days after randomization ] [ Designated as safety issue: No ]
  • TIMI major bleeding [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
    Thrombolysis in Myocardial Infarction-defined major bleeding complications


Estimated Enrollment: 100
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (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

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  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493999

Locations
Hungary
University of Pécs, Heart Institute
Pécs, Hungary, 7624
Sponsors and Collaborators
University of Pecs
Investigators
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

No publications provided

Responsible Party: Daniel Aradi MD, Assisstant Professor, University of Pecs
ClinicalTrials.gov Identifier: NCT01493999     History of Changes
Other Study ID Numbers: PECS-002
Study First Received: December 14, 2011
Last Updated: January 28, 2013
Health Authority: Hungary: National Institute of Pharmacy

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

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013