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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
 Drug: Prasugrel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • PRI Levels at 4 Hours [ Time Frame: 4 hours after treatment ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prasugrel 60mg
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
 Drug: Prasugrel
Prasugrel 10mg, 30mg, or 60mg
Active Comparator: Prasugrel 30mg
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
 Drug: Prasugrel
Prasugrel 10mg, 30mg, or 60mg
No Intervention: Prasugrel 10mg
Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201772

Locations
United States, Florida
University of Florida
Jacksonville, Florida, United States, 32209
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Dominick Angiolillo, MD, PhD University of Florida
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01201772     History of Changes
Other Study ID Numbers: UFJ 2010-49
Study First Received: September 3, 2010
Results First Received: January 9, 2013
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
coronary artery disease
percutaneous coronary revascularization
prasugrel therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Prasugrel
 Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013