- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01523392
A Pharmacodynamic Study With Ticagrelor in African American Patients
September 30, 2014 updated by: AstraZeneca
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in African American Patients With Stable Coronary Artery Disease
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in African American Patients with Stable Coronary Artery Disease
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delaware
-
Newark, Delaware, United States
- Research Site
-
Wilmington, Delaware, United States
- Research Site
-
-
District of Columbia
-
Washington, District of Columbia, United States
- Research Site
-
-
Florida
-
Hollywood, Florida, United States
- Research Site
-
Jacksonville, Florida, United States
- Research Site
-
-
Georgia
-
Atlanta, Georgia, United States
- Research Site
-
-
Maryland
-
Towson, Maryland, United States
- Research Site
-
-
Texas
-
Beaumont, Texas, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provision of signed and dated informed consent before initiation of any study-related procedures
- Male or female patients aged 18 years or older
- Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
- Females must be post menopausal or surgically sterile Self-identified as African American
Exclusion Criteria:
- Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
- Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
- Current smokers, including the use of tobacco containing products in the past 1 month of randomization Patients required dialysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Clopidogrel
|
75mg (once daily)/Max - 600mg tablets (loading dose)
|
Experimental: Ticagrelor
|
Min - 90mg/Max - 180mg tablets (loading dose)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
Time Frame: At 2 hours after the loading dose
|
At 2 hours after the loading dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose
Time Frame: At 0.5 hour and 8 hours after the loading dose
|
At 0.5 hour and 8 hours after the loading dose
|
|
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8
Time Frame: At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8
|
At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8
|
|
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
Time Frame: Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose
|
The standard deviation (SD) is the geometric SD
|
Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose
|
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
Time Frame: Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose
|
The standard deviation (SD) is the geometric SD
|
Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Glenn Carlson, MD, AstraZeneca Pharmaceuticals Room C3B-718PO Box 15437 Wilmington, DE 19850-5437 USA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
January 30, 2012
First Submitted That Met QC Criteria
January 30, 2012
First Posted (Estimate)
February 1, 2012
Study Record Updates
Last Update Posted (Estimate)
October 8, 2014
Last Update Submitted That Met QC Criteria
September 30, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
- Clopidogrel
Other Study ID Numbers
- D5130L00013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stable Coronary Artery Disease
-
Ajou University School of MedicineB. Braun Korea Co., Ltd.UnknownStable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery DiseaseKorea, Republic of
-
SanofiTerminatedMicrovascular Coronary Artery DiseaseUnited States, Denmark, Korea, Republic of, Netherlands, Sweden
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
AstraZenecaCompletedStable Coronary Artery DiseaseUnited States
-
AstraZenecaCompletedStable Coronary Artery DiseasePhilippines, Japan
-
AstraZenecaCompletedStable Coronary Artery DiseaseUnited States, Canada, Denmark, United Kingdom
-
Nanhai Hospital, Guangdong Provincial People's...RecruitingStable Coronary Artery DiseaseChina
-
Institute of Cardiology, Warsaw, PolandMinisterstwo Nauki i Szkolnictwa Wyższego, Warszawa, PolskaCompletedStable Coronary Artery DiseasePoland
-
Onze Lieve Vrouw HospitalCompletedStable Coronary Artery DiseaseBelgium
-
IRCCS Policlinico S. MatteoTerminated
Clinical Trials on Ticagrelor
-
Collegium Medicum w BydgoszczyCompleted
-
Federico II UniversityAdvicePharma GroupCompletedMyocardial Infarction | Coronary Artery Disease | Acute Coronary Syndrome | STEMI | NSTEMIItaly
-
University of FloridaCompleted
-
AstraZenecaParexelCompletedSickle Cell DiseaseGermany
-
University of FloridaAstraZenecaCompleted
-
University of FloridaThe Medicines CompanyCompletedCoronary Artery DiseaseUnited States
-
Centro Hospitalario La ConcepcionRecruiting
-
Sheba Medical CenterCompletedST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
David AntoniucciAstraZeneca; A.R. CARD Onlus FoundationCompletedAcute Coronary Syndrome | Adverse Reaction to Antiplatelet AgentItaly, Greece
-
Weill Medical College of Cornell UniversityCanadian Institutes of Health Research (CIHR)Not yet recruitingChronic Coronary DiseaseUnited States, Austria, Canada, Germany, Sweden