NCT01493999

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

December 14, 2011

Last Update Submit

October 6, 2014

Conditions

Acute Coronary Syndrome

Keywords

ClopidogrelprasugrelHPRloading dosemaintenance dosestent thrombosisplatelet reactivityCoronary interventionstent implantation

Outcome Measures

Primary Outcomes (1)

  • ADP-reactivity between clopidogrel reloading and prasugrel arm

    Multiplate-assessed ADP-reactivity (area under curve, U)

    4 days after randomization

Secondary Outcomes (6)

  • The proportion of patients with HPR

    4 days after randomization

  • ADP-reactivity between clopidogrel and prasugrel arms

    30 days after randomization

  • The proportion of patients with HPR between clopidogrel and prasugrel arms

    30 days after randomization

  • VASP-PRI between clopidogrel and prasugrel patients

    30 days after randomization

  • Cardiovascular death, myocardial infarction or definite/probable stent thrombosis

    30 days after randomization

  • +1 more secondary outcomes

Study Arms (2)

Prasugrel arm

ACTIVE COMPARATOR

A loading dose of 60 mg prasugrel in patients with HPR after 600 mg clopidogrel.

Drug: Prasugrel

Clopidogrel reloading

ACTIVE COMPARATOR

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

Interventions

Clopidogrel reloadingDRUG

Up to three times 600 mg clopidogrel

Also known as: Clopidogrel = KARDOGREL
Clopidogrel reloading
PrasugrelDRUG

60 mg prasugrel in patients with HPR

Also known as: Prasugrel = EFIENT
Prasugrel arm

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pécs, Heart Institute

Pécs, 7624, Hungary

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dániel Aradi, MD PhD

    University of Pécs, Heart Institute, Hungary

    PRINCIPAL INVESTIGATOR

  • András Komócsi, MD PhD

    University of Pécs, Heart Institute, Hungary

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

December 14, 2011

First Posted

December 16, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

October 8, 2014

Record last verified: 2014-10

Locations

HU(1)