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Phase 4 N=65 Randomized Diagnostic

Prasugrel Re-load Strategies

Coronary Artery Disease

Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: PRI Levels at 4 Hours — 28.8; 11; 2.8 percentage of platelet reactivity

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Prasugrel (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Florida
Primary completion
May 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
PRI Levels at 4 Hours
28.8; 11; 2.8

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.

Eligibility Criteria

Inclusion Criteria

  • Patients with angiographically documented coronary artery disease.
  • Age between 18 to 74 years
  • On treatment with prasugrel 10mg/daily for at least 14 days.

Exclusion Criteria

  • Blood dyscrasias or bleeding diathesis
  • Antiplatelet treatment with clopidogrel or ticlopidine
  • Recent antiplatelet treatment ( 2 mg/dL
  • Baseline ALT >2.5 times the upper limit of normal
  • Oral anticoagulation with a coumarin derivative
  • History of stroke, TIA or intracranial bleeding
  • Weight <60kg
  • Pregnant females
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01201772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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