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Prasugrel Re-load Strategies

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prasugrel
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery disease, percutaneous coronary revascularization, prasugrel therapy

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Prasugrel 60mg

Prasugrel 30mg

Prasugrel 10mg

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

PRI Levels at 4 Hours

Secondary Outcome Measures

Full Information

First Posted
September 3, 2010
Last Updated
January 17, 2013
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01201772
Brief Title
Prasugrel Re-load Strategies
Official Title
Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, percutaneous coronary revascularization, prasugrel therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prasugrel 60mg
Arm Type
Active Comparator
Arm Description
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
Arm Title
Prasugrel 30mg
Arm Type
Active Comparator
Arm Description
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
Arm Title
Prasugrel 10mg
Arm Type
No Intervention
Arm Description
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
Intervention Type
Drug
Intervention Name(s)
Prasugrel
Intervention Description
Prasugrel 10mg, 30mg, or 60mg
Primary Outcome Measure Information:
Title
PRI Levels at 4 Hours
Time Frame
4 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with angiographically documented coronary artery disease. Age between 18 to 74 years On treatment with prasugrel 10mg/daily for at least 14 days. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominick Angiolillo, MD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22554598
Citation
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.
Results Reference
result

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Prasugrel Re-load Strategies

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