Prasugrel Re-load Strategies

University of Florida

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Prasugrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01201772

UFJ 2010-49

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

Prasugrel 60mg

Active Comparator group

Description:

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

Treatment:

Drug: Prasugrel

Prasugrel 30mg

Active Comparator group

Description:

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

Treatment:

Drug: Prasugrel

Prasugrel 10mg

No Intervention group

Description:

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