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Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
Rapid City Regional Hospital, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Heart Doctors/Black Hills Cardiovascular Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor

Clopidogrel

Arm Description

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

Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days

Outcomes

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.

Secondary Outcome Measures

Compare the decrease of P2Y12 Reaction Units (PRU) by VerifyNow TM from ticagrelor and clopidogrel.
Compare the decrease in P2Y l2 Reaction Units (PRU) by VerifyNow™ from ticagrelor's and clopidogrel's morning dose on Day 7
To evaluate and compare the pharmacodynamic effects, measured by the vasodilator-stimulated phosphoprotein (VASP) assay (platelet reactivity index [PRI]), in all subjects
Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment.
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

Full Information

First Posted
October 10, 2012
Last Updated
May 4, 2015
Sponsor
Rapid City Regional Hospital, Inc
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01706510
Brief Title
Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rapid City Regional Hospital, Inc
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Description
Clopidogrel 600 mg Loading Dose followed by 75 mg Daily for 7 days ± 2 days
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
Brand Name: Brilinta
Intervention Description
Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Brand Name: Plavix
Intervention Description
Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
Assess and to compare the percentage of subjects with High on-treatment Platelet Reactivity (HPR) at all time points after randomized study treatment.
Description
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
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
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S Walder, MD
Organizational Affiliation
Rapid City Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Heart Doctors/Black Hills Cardiovascular Research
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States

12. IPD Sharing Statement

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Antiplatelet Effects of Ticagrelor Versus Clopidogrel in American Indian Patients

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