A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.

Detailed Description
-----------------
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease

Official Title
-----------------
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Hispanic Patients With Stable Coronary Artery Disease

Conditions
-----------------
Stable Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Hispanic 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 requiring dialysis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br> | Drug: Ticagrelor<br>* Min - 90mg/Max - 180mg tablets (loading dose)<br>|
| Active Comparator: Clopidogrel<br> | Drug: Clopidogrel<br>* 75mg (once daily)/Max - 600mg tablets (loading dose)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose | Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value | 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 and 8 Hours After Loading Dose | Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value | At 0.5 and 8 hours after the loading dose | 
| Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8 | The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value | At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8 | 
| Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses | The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD. | Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose | 
| AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses | The SD is a statistic using the log-transformed data and is not the geometric SD. | Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stable Coronary Artery Disease, CAD