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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
History of Changes
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
 Drug: Ticagrelor
Drug: Clopidogrel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rapid City Regional Hospital, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 34
Study Start Date: December 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
 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
Active Comparator: Clopidogrel
Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days
 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706510

Contacts
Contact: Roger E DeRaad, MN, CNP 605-381-5621 rderaad@regionalhealth.com
Contact: Denice Hockett, RN 605-718-2610 dhockett@regionalhealth.com

Locations
United States, South Dakota
Regional Heart Doctors/Black Hills Cardiovascular Research Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Roger E DeRaad, MN, CNP     605-718-2610     rderaad@regionalhealth.com    
Contact: Denice Hockett, RN     605-718-2610     dhockett@regionalhealth.com    
Principal Investigator: James S Walder, MD            
Sub-Investigator: Roger E DeRaad, MN, CNP            
Sponsors and Collaborators
Rapid City Regional Hospital, Inc
AstraZeneca
Investigators
Principal Investigator: James S Walder, MD Rapid City Regional Hospital
  More Information

No publications provided

Responsible Party: Rapid City Regional Hospital, Inc
ClinicalTrials.gov Identifier: NCT01706510     History of Changes
Other Study ID Numbers: ISSBRIL0076
Study First Received: October 10, 2012
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rapid City Regional Hospital, Inc:
Clopidogrel
Ticagrelor
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Physiological Effects of Drugs

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Ticlopidine
Ticagrelor
Purinergic P2Y Receptor Antagonists
 Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Physiological Effects of Drugs
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013