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

AstraZeneca146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

146

Conditions

Stable Coronary Artery Disease

Interventions

ticagrelorDRUG

Drug oral treatment

clopidogrelDRUG

Drug oral treatment

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (13)

Research Site

Miyaodai, Fukuoka, Japan

Research Site

Sapporo, Hokkaido, Japan

Research Site

Toride-shi, Ibaraki, Japan

Research Site

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week 4

IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients

Time frame: Week 4

IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients

Data from ClinicalTrials.gov

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Secondary Outcomes

AZD6140 (Cmax) at Week 4

Maximum plasma AZD6140 concentration

Time frame: Week 4

AZD6140 (AUC0-tau) at Week 4

Area under the plasma concentration curve of AZD6140 from time zero to dosing interval

Time frame: Week 4

AZD6140 (Tmax) at Week 4

Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration

Time frame: Week 4

AR-C124910XX (Cmax) at Week 4

Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX

Time frame: 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

Time frame: Week 4

AR-C124910XX (Tmax) at Week 4

Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration

Time frame: Week 4