NCT02070159

Brief Summary

Although prasugrel, recently available thienopyridine derivative, exhibits rapid and potent platelet inhibition, concerns of low on-treatment platelet reactivity have been suggested especially in East Asian ethnicities. The investigators compared the effect of lower loading dose of prasugrel with conventional loading dose of clopidogrel and prasugrel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at below P25 for phase_3 coronary-artery-disease

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_3 coronary-artery-disease

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

December 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

February 8, 2014

Last Update Submit

February 21, 2014

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaseprasugrelplatelet function tests

Outcome Measures

Primary Outcomes (1)

  • Platelet reactivity

    Platelet reactivity was measured using traditional light transmission aggregometry (LTA), VerifyNow (Accumetrics, San Diego, CA, USA), and multiple electrode aggregometry (MEA, Dynabyte Medical, Munich, Germany). The platelet reactivity was measured at 6 hours after study drug administration (after 2 hours for the prasugrel groups).

    at 6 hours after administration of study drug. (2 hours for prasugrel groups)

Secondary Outcomes (5)

  • Percent inhibition

    at 6 hours after administration of study drug. (2 hours for prasugrel groups)

  • HPR

    at 6 hours after administration of study drug. (2 hours for prasugrel groups)

  • LPR

    at 6 hours after administration of study drug. (2 hours for prasugrel groups)

  • Bleeding event

    30 days after study drug administration

  • Adverse reaction

    30 days after study drug administration

Study Arms (3)

Clopidogrel 600 mg

ACTIVE COMPARATOR

Patients administer conventional loading dose of clopidogrel 600 mg as active comparators.

Drug: Clopidogrel 600 mg

Prasugrel 30 mg

EXPERIMENTAL

Patients administer lower loading dose of prasugrel 30 mg.

Drug: Prasugrel 30 mg

Prasugrel 60 mg

ACTIVE COMPARATOR

Patients administer conventional loading dose of prasugrel 60 mg as active comparators.

Drug: Prasugrel 60 mg

Interventions

Clopidogrel 600 mgDRUG

Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel

Also known as: Plavix 600 mg
Clopidogrel 600 mg
Prasugrel 30 mgDRUG

Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.

Also known as: Effient 30 mg
Prasugrel 30 mg
Prasugrel 60 mgDRUG

Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.

Also known as: Effient 60 mg
Prasugrel 60 mg

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 and 80 years
  • Stable or unstable angina
  • Planned to undergo elective coronary angiography

You may not qualify if:

  • Previous history of transient ischemic attack or stroke
  • Intracranial neoplasm
  • Uncontrolled malignant disease
  • History of antiplatelet or anticoagulation treatment within 1 month
  • Contraindication to the study drug
  • Bleeding diathesis
  • Hemoglobin \< 10 g/dl
  • Platelet count \< 100,000/mm3
  • Significant renal insufficiency (glomerular filtration rate \<60 mL/min/1.73 m2)
  • Significant hepatic impairment (Serum liver enzyme or bilirubin \> 3 times normal limit)
  • Body weight \< 50 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DongA University Hospital

Busan, 602-715, South Korea

Location

Related Publications (1)

  • Kim MH, Zhang HZ, Jung DK. Pharmacodynamic comparisons for single loading doses of prasugrel (30 mg) and clopidogrel (600 mg) in healthy Korean volunteers. Circ J. 2013;77(5):1253-9. doi: 10.1253/circj.cj-12-0783. Epub 2013 Jan 30.

    PMID: 23363643BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

ClopidogrelPrasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperazines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Director, Regional Clinical Trial Center. Professor, Dept. of Cardiology Dong-A University Hospital

Study Record Dates

First Submitted

February 8, 2014

First Posted

February 25, 2014

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

KR(1)