- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01201772
Prasugrel Re-load Strategies
January 17, 2013 updated by: University of Florida
Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Jacksonville, Florida, United States, 32209
- University of Florida
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Prasugrel 60mg
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
|
Prasugrel 10mg, 30mg, or 60mg
|
Active Comparator: Prasugrel 30mg
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
|
Prasugrel 10mg, 30mg, or 60mg
|
No Intervention: Prasugrel 10mg
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PRI Levels at 4 Hours
Time Frame: 4 hours after treatment
|
4 hours after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
September 3, 2010
First Submitted That Met QC Criteria
September 14, 2010
First Posted (Estimate)
September 15, 2010
Study Record Updates
Last Update Posted (Estimate)
January 18, 2013
Last Update Submitted That Met QC Criteria
January 17, 2013
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFJ 2010-49
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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