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Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

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ClinicalTrials.gov Identifier: NCT01706510
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : May 5, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Assess the pharmacodynamic effect of ticagrelor vs. Clopidogrel in American Indian patients with stable coronary artery disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Ticagrelor Drug: Clopidogrel Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : December 2012
Primary Completion Date : March 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

    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:
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01706510


Locations
United States, South Dakota
Regional Heart Doctors/Black Hills Cardiovascular Research
Rapid City, South Dakota, United States, 57701
Sponsors and Collaborators
Rapid City Regional Hospital, Inc
AstraZeneca
Investigators
Principal Investigator: James S Walder, MD Rapid City Regional Hospital
More Information

Responsible Party: Rapid City Regional Hospital, Inc
ClinicalTrials.gov Identifier: NCT01706510     History of Changes
Other Study ID Numbers: ISSBRIL0076
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

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
Ticlopidine
Platelet Aggregation Inhibitors
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors