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OpenTrials
Completed

NCT Number: NCT01201772

Prasugrel Re-load Strategies

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Jacksonville, Florida, 32209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (< 14 days) with a glycoprotein IIb/IIIa antagonist
  • Platelet count <100x106/µL
  • Active bleeding or hemodynamic instability.
  • Unstable angina, acute or recent (<14 days) myocardial infarction.
  • Serum creatinine >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

Treatment and study plan

Prasugrel

Drug

Prasugrel 10mg, 30mg, or 60mg

Primary outcomes

  1. PRI Levels at 4 Hours

    Time frame: 4 hours after treatment

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 15, 2010
Registry last updated
Jan 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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