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Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT01852175
Recruitment Status : Completed
First Posted : May 13, 2013
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects compared with clopidogrel and are associated with an improved net clinical benefit. However, to date there are limited head-to-head comparisons of these two new agents.

Condition or disease Intervention/treatment
Coronary Artery Disease Drug: Prasugrel Drug: Ticagrelor

Detailed Description:
Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of thrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have recurrent ischemic events despite this treatment regimen. These observations underscore the need for more potent antiplatelet therapies. Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor. Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects compared with clopidogrel. These more favorable pharmacodynamic effects translate into reduced ischemic event rates, at the expense of an increased risk of bleeding in patients with acute coronary syndromes. Overall, these drugs are associated with an improved net clinical benefit. These findings from large-scale clinical investigations have led to approval of prasugrel and ticagrelor. However, to date there are limited head-to-head comparisons of these two new agents.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A head-to Head Comparison of the Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
Study Start Date : January 2012
Primary Completion Date : June 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Prasugrel
Prasugrel 60mg loading dose and 10 mg maintenance dose
Drug: Prasugrel
Prasugrel 60mg loading dose and 10mg maintenance dose
Other Name: Effient
Active Comparator: Ticagrelor
Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Drug: Ticagrelor
Ticagrelor 180mg loading dose and 90mg bid maintenance dose
Other Name: Brillinta


Outcome Measures

Primary Outcome Measures :
  1. Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) [ Time Frame: 1 week ]
    The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.


Secondary Outcome Measures :
  1. Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP) [ Time Frame: 2 hours ]
    A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.

  2. Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP) [ Time Frame: 24 hours ]
    A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with known coronary artery disease
  • On maintenance treatment with aspirin (81 mg per day) and clopidogrel (75 mg per day) for at least 1-month as per standard of care.
  • Age between 18 and 74 years old.

Exclusion Criteria:

  • History of stroke, transient ischemic attack or intracranial bleeding.
  • Known allergies to aspirin, prasugrel, ticagrelor, or clopidogrel.
  • Weight <60kg
  • On treatment with oral anticoagulation (coumarin derivate, dabigatran).
  • Hemoglobin<10 gm/dL
  • Platelet count <80x106/mL
  • Active bleeding or hemodynamic instability.
  • Creatinine Clearance <30 mL/minute.
  • Baseline ALT >2.5 times the upper limit of normal.
  • Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
  • Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel): , fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).
  • Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
  • Pregnant females*. *Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852175


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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01852175     History of Changes
Other Study ID Numbers: UFJ 2011-143
First Posted: May 13, 2013    Key Record Dates
Results First Posted: June 10, 2015
Last Update Posted: June 10, 2015
Last Verified: August 2014

Keywords provided by University of Florida:
Coronary artery disease
Dual antiplatelet therapy
prasugrel
ticagrelor

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