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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01852175
First received: May 8, 2013
Last updated: August 6, 2014
Last verified: August 2014

May 8, 2013
August 6, 2014
January 2012
June 2014   (final data collection date for primary outcome measure)
Platelet reactivity [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01852175 on ClinicalTrials.gov Archive Site
Markers of platelet reactivity [ Time Frame: 2 hour and 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
A head-to Head Comparison of the Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Prasugrel
    Prasugrel 60mg loading dose and 10mg maintenance dose
    Other Name: Effient
  • Drug: Ticagrelor
    Ticagrelor 180mg loading dose and 90mg bid maintenance dose
    Other Name: Brillinta
  • Active Comparator: Prasugrel
    Prasugrel 60mg loading dose and 10 mg maintenance dose
    Interventions:
    • Drug: Prasugrel
    • Drug: Ticagrelor
  • Active Comparator: Ticagrelor
    Ticagrelor 180mg loading dose and 90mg bid maintenance dose
    Interventions:
    • Drug: Prasugrel
    • Drug: Ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
July 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01852175
UFJ 2011-143
Yes
University of Florida
University of Florida
Not Provided
Principal Investigator: Dominick Angiolillo, MD, PhD University of Florida
University of Florida
August 2014

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