Prasugrel Re-load Strategies

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Prasugrel

• Registration Number: NCT01201772
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Primary Completion: 2011-05
• Study Completion: 2011-09
• Status Verified: 2011-12
• Results First Submitted: 2013-01-09
• Results First Submitted QC: 2013-01-17
• Last Update Submitted: 2013-01-17
• Results First Posted: 2013-01-18
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel 30mg	Prasugrel	Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
Prasugrel 60mg	Prasugrel	Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel

Primary Outcome Measures

Name	Time	Method
PRI Levels at 4 Hours	4 hours after treatment

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States