Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

This study is currently recruiting participants.
Verified April 2013 by Rapid City Regional Hospital, Inc
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Rapid City Regional Hospital, Inc
ClinicalTrials.gov Identifier:
NCT01706510
First received: October 10, 2012
Last updated: April 10, 2013
Last verified: April 2013

October 10, 2012
April 10, 2013
December 2012
March 2014   (final data collection date for primary outcome measure)
Compare ticagrelor's versus clopidogrel's inhibition of the P2Y12 receptor as measured by the decrease in P2Y12 Reaction Units (PRU) using VerifyNow TM. [ Time Frame: At 2 hour time point after loading dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01706510 on ClinicalTrials.gov Archive Site
  • Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel. [ Time Frame: 0.5 and 8 hour time points after loading dose ] [ Designated as safety issue: No ]
  • Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNow™ from ticagrelor's and clopidogrel's morning dose on Day 7 [ Time Frame: At the 2, 8, and 24 hours after the last dose ] [ Designated as safety issue: No ]
  • To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects [ Time Frame: Day1: pre-dose, 0.5, 2, and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours post final dose ] [ Designated as safety issue: No ]
  • Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment. [ Time Frame: Day 1: Pre-dose, 0.5, 2 and 8 hours post loading dose Day 7: pre-dose, 2 and 8 hours post dose Day 8: 24 hours after final dose ] [ Designated as safety issue: No ]

    The High on-treatment Platelet Reactivity will be defined in accordance with the following platelet inhibition level cut-off.

    • > 208 PRU by the VerifyNow P2Y12 assay
    • > 230 PRU by the VerifyNow P2Y12 assay
    • > 50% PRI by the VASP assay
Same as current
CYP2C19 genotyping to identifying the wild-type CYP2C19 allele (*1), and characterize common alleles known to effect the metabolism of clopidogrel (*2, *3, *4,*5,*6,*7,*8 responsible for poor metabolism and *17 allele responsible for rapid metabolism). [ Time Frame: One time-point ] [ Designated as safety issue: No ]
Same as current
 
Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients
A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease

Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.

A Single Center, Randomized, Open Label, Multiple Dose, Crossover Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients With Stable Coronary Artery Disease

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Drug: Ticagrelor
    Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
    Other Name: Brand Name: Brilinta
  • Drug: Clopidogrel
    Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days
    Other Name: Brand Name: Plavix
  • Experimental: Ticagrelor
    Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
    Interventions:
    • Drug: Ticagrelor
    • Drug: Clopidogrel
  • Active Comparator: Clopidogrel
    Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days
    Interventions:
    • Drug: Ticagrelor
    • Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
April 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented stable CAD fulfilling any of the following, and taking 81mg ASA daily treatment:
  • Females must be post menopausal for at least one year or surgically sterile for at least 6 months and negative urine pregnancy test
  • Self-identified as American Indian
  • Genetic Inclusion Criteria: must sign the informed consent for genetic and biological sample banking.

Exclusion Criteria:

  • Any indication for oral anticoagulant or dual antiplatelet treatment
  • Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers within 14 days and during study treatment and during:
  • Increased bleeding risk including:
  • Diabetic patients with HbAlC > 10% at screening
  • Contraindication to clopidogrel, ASA, or ticagrelor - A history of alcohol and/or substance abuse that could interfere with conduct of the trial
  • Patients requiring dialysis
  • Patients scheduled for revascularization (e.g., PCI, CABG) during the study period
  • Any acute or chronic unstable condition in the past 30 days
  • Known active or recurrent hepatic disorder
  • Patients who had ACS or stent placed within 12 months of screening
  • History of Uric Acid nephropathy
Both
18 Years and older
No
Contact: Roger E DeRaad, MN, CNP 605-381-5621 rderaad@regionalhealth.com
Contact: Denice Hockett, RN 605-718-2610 dhockett@regionalhealth.com
United States
 
NCT01706510
ISSBRIL0076
No
Rapid City Regional Hospital, Inc
Rapid City Regional Hospital, Inc
AstraZeneca
Principal Investigator: James S Walder, MD Rapid City Regional Hospital
Rapid City Regional Hospital, Inc
April 2013

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