Prasugrel Re-load Strategies
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prasugrel
Sponsored by
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
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
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
NCT ID
NCT01201772
First Posted
September 3, 2010
Last Updated
January 17, 2013
Sponsor
University of Florida
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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