An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease

Study Overview
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Brief Summary
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The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.

Official Title
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A Randomised, Double-Blind, Parallel Group, Asian, Multicenter Study, to Assess Pharmacokinetic and Pharmacodynamic Profile of 2 Doses of Ticagrelor on Top of Low Dose Acetyl Salicylic Acid (ASA) Therapy on Platelet Aggregation in Japanese and Asian Patients With Stable Coronary Artery Disease

Conditions
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Stable Coronary Artery Disease

Intervention / Treatment
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* Drug: ticagrelor
* Drug: clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any Percutaneous Coronary Intervention, more than 3 months prior to randomization Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation Treatment with ASA Exclusion Criteria: ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation Known concurrent disease of stroke or TIA with atrial fibrillation Persons who are being treated with blood clotting agents that cannot be stopped

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD6140 45 mg bd<br> | Drug: ticagrelor<br>* Drug oral treatment<br>|
| Experimental: AZD6140 90 mg bd<br> | Drug: ticagrelor<br>* Drug oral treatment<br>|
| Active Comparator: Clopidogrel 75 mg od<br> | Drug: clopidogrel<br>* Drug oral treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for Adenosine Diphosphate (ADP)-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) Platelet Aggregation (PA) was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Week 4 | 
| IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Week 4 | 
| IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Week 4 | 
| IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Week 4 | 
| IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients | Final extent IPA from pre-dose baseline was calculated using the following formula for ADP-induced platelet aggregation: Percentage Inhibition = 100% x (PAs - PA) / (PAs) PA was the mean response at the given post dose time point and PAs was the mean response at pre dose baseline. Percentage inhibition was restricted to the closed interval [0,100]; any data falling outside this range was truncated to the appropriate limit. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AZD6140 (Cmax) at Week 4 | Maximum plasma AZD6140 concentration | Week 4 | 
| AZD6140 (AUC0-tau) at Week 4 | Area under the plasma concentration curve of AZD6140 from time zero to dosing interval | Week 4 | 
| AZD6140 (Tmax) at Week 4 | Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration | Week 4 | 
| AR-C124910XX (Cmax) at Week 4 | Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX | Week 4 | 
| AR-C124910XX (AUC0-tau) at Week 4 | Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval | Week 4 | 
| AR-C124910XX (Tmax) at Week 4 | Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stable Coronary Artery Disease, Platelet Aggregation