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

Phase 2

Completed

• Conditions: Stable Coronary Artery Disease
• Interventions: Drug: ticagrelor; Drug: clopidogrel

• Registration Number: NCT01118325
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-30
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Disposition First Submitted: 2011-02-23
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Disposition First Submitted QC: 2011-06-01
• Disposition First Posted: 2011-06-07
• Results First Submitted: 2012-03-14
• Results First Submitted QC: 2012-03-14
• Results First Posted: 2012-04-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD6140 45 mg bd	ticagrelor	-
AZD6140 90 mg bd	ticagrelor	-
Clopidogrel 75 mg od	clopidogrel	-

Primary Outcome Measures

Name	Time	Method
Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients	Week 4	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.
IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients	Week 4	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.
IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients	Week 4	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.
IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients	Week 4	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.
IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients	Week 4	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇵🇭 Quezon City, Philippines