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NCT Number: NCT01706510

Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regional Heart Doctors/Black Hills Cardiovascular Research

Rapid City, South Dakota, 57701, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days

Other names: Brand Name: Brilinta

clopidogrel

Drug

Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days

Other names: Brand Name: Plavix

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rapid City Regional Hospital, Inc

Other

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 15, 2012
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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