NCT01201772

Brief Summary

A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior observations showing that higher inhibition of platelet aggregation may be achieved by giving a loading dose of clopidogrel in patients with coronary artery disease while on chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a prasugrel loading dose in patients on chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be useful.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4 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

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 18, 2013

Completed
Last Updated

January 18, 2013

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

September 3, 2010

Results QC Date

January 9, 2013

Last Update Submit

January 17, 2013

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasepercutaneous coronary revascularizationprasugrel therapy

Outcome Measures

Primary Outcomes (1)

  • PRI Levels at 4 Hours

    4 hours after treatment

Study Arms (3)

Prasugrel 60mg

ACTIVE COMPARATOR

Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel

Drug: Prasugrel

Prasugrel 30mg

ACTIVE COMPARATOR

Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel

Drug: Prasugrel

Prasugrel 10mg

NO INTERVENTION

Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel

Interventions

PrasugrelDRUG

Prasugrel 10mg, 30mg, or 60mg

Prasugrel 30mgPrasugrel 60mg

Eligibility Criteria

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

You may qualify if:

  • Patients with angiographically documented coronary artery disease.
  • Age between 18 to 74 years
  • On treatment with prasugrel 10mg/daily for at least 14 days.

You may not qualify if:

  • Blood dyscrasias or bleeding diathesis
  • Antiplatelet treatment with clopidogrel or ticlopidine
  • Recent antiplatelet treatment (\< 14 days) with a glycoprotein IIb/IIIa antagonist
  • Platelet count \<100x106/µL
  • Active bleeding or hemodynamic instability.
  • Unstable angina, acute or recent (\<14 days) myocardial infarction.
  • Serum creatinine \>2 mg/dL
  • Baseline ALT \>2.5 times the upper limit of normal
  • Oral anticoagulation with a coumarin derivative
  • History of stroke, TIA or intracranial bleeding
  • Weight \<60kg
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

  • Tello-Montoliu A, Tomasello SD, Ferreiro JL, Ueno M, Seecheran N, Desai B, Kodali M, Charlton RK, Box LC, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. Pharmacodynamic effects of prasugrel dosing regimens in patients on maintenance prasugrel therapy: results of a prospective randomized study. J Am Coll Cardiol. 2012 May 8;59(19):1681-7. doi: 10.1016/j.jacc.2011.12.039.

    PMID: 22554598RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dominick Angiolillo
Organization
University of Florida
dominick.angiolillo@jax.ufl.edu
904-244-3933

Study Officials

  • Dominick Angiolillo, MD, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 15, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2011

Study Completion

September 1, 2011

Last Updated

January 18, 2013

Results First Posted

January 18, 2013

Record last verified: 2011-12

Locations

US(1)