Prasugrel Re-load Strategies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01201772
First received: September 3, 2010
Last updated: January 17, 2013
Last verified: December 2011

September 3, 2010
January 17, 2013
August 2010
May 2011   (final data collection date for primary outcome measure)
PRI Levels at 4 Hours [ Time Frame: 4 hours after treatment ] [ Designated as safety issue: No ]
Platelet function [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Platelet function as assessed by VASP-P, LTA following ADP stimuli and VerifyNow
Complete list of historical versions of study NCT01201772 on ClinicalTrials.gov Archive Site
Not Provided
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Prasugrel Re-load Strategies
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
Drug: Prasugrel
Prasugrel 10mg, 30mg, or 60mg
  • Active Comparator: Prasugrel 60mg
    Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
    Intervention: Drug: Prasugrel
  • Active Comparator: Prasugrel 30mg
    Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
    Intervention: Drug: Prasugrel
  • No Intervention: Prasugrel 10mg
    Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
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: results of a prospective randomized study. J Am Coll Cardiol. 2012 May 8;59(19):1681-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
September 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01201772
UFJ 2010-49
Yes
University of Florida
University of Florida
Not Provided
Principal Investigator: Dominick Angiolillo, MD, PhD University of Florida
University of Florida
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP