Prasugrel Re-load Strategies

Coronary Artery Disease Clinical Trial

Official title:

Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201772
• Other study ID #: UFJ 2010-49
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2010
• Last updated: January 17, 2013
• Start date: August 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2011
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Prasugrel
Prasugrel 10mg, 30mg, or 60mg

Locations

Country	Name	City	State
United States	University of Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: resul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRI Levels at 4 Hours		4 hours after treatment	No