Prasugrel Re-load Strategies
Information source: University of Florida
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Prasugrel (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Florida Overall contact:
Dominick Angiolillo, MD, PhD, Phone: 904-244-3933, Email: dominick.angiolillo@jax.ufl.edu
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.
Clinical Details
Official title: Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Platelet function
Eligibility
Minimum age: 18 Years.
Maximum age: 74 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dominick Angiolillo, MD, PhD, Phone: 904-244-3933, Email: dominick.angiolillo@jax.ufl.edu
University of Florida, Jacksonville, Florida 32209, United States; Recruiting
Dominick Angiolillo, MD, PhD, Phone: 904-244-3933, Email: dominick.angiolillo@jax.ufl.edu
Dominick Angiolillo, MD, PhD, Principal Investigator
Additional Information
Starting date: August 2010
Last updated: September 14, 2010
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