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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Stable Coronary Artery Disease	Drug: ticagrelor; Drug: clopidogrel	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	146 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	April 2010
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: AZD6140 45 mg bd	Drug: ticagrelor; Drug oral treatment
Experimental: AZD6140 90 mg bd	Drug: ticagrelor; Drug oral treatment
Active Comparator: Clopidogrel 75 mg od	Drug: clopidogrel; Drug oral treatment

Outcome Measures

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Primary Outcome Measures :

1. Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients [ Time Frame: 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.

2. IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients [ Time Frame: 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.

3. IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients [ Time Frame: 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.

4. IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients [ Time Frame: 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.

5. IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients [ Time Frame: 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 :

1. AZD6140 (Cmax) at Week 4 [ Time Frame: Week 4 ]
   Maximum plasma AZD6140 concentration
2. AZD6140 (AUC0-tau) at Week 4 [ Time Frame: Week 4 ]
   Area under the plasma concentration curve of AZD6140 from time zero to dosing interval
3. AZD6140 (Tmax) at Week 4 [ Time Frame: Week 4 ]
   Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration
4. AR-C124910XX (Cmax) at Week 4 [ Time Frame: Week 4 ]
   Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX
5. AR-C124910XX (AUC0-tau) at Week 4 [ Time Frame: Week 4 ]
   Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval
6. AR-C124910XX (Tmax) at Week 4 [ Time Frame: Week 4 ]
   Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Japan
Research Site
Mizumaki, Fukuoka, Japan
Research Site
Sapporo-shi, Hokkaido, Japan
Research Site
Toride-shi, Ibaraki, Japan
Research Site
Kawasaki-shi, Kanagawa, Japan
Research Site
Kyoto-shi, Kyoto, Japan
Research Site
Naha-shi, Okinawa, Japan
Research Site
Osaka-shi, Osaka, Japan
Research Site
Kusatsu-shi, Shiga, Japan
Research Site
Komatsushima-shi, Tokushima, Japan
Research Site
Shinagawa-ku, Tokyo, Japan
Research Site
Oita, Japan
Research Site
Osaka, Japan
Philippines
Research Site
Davao City, Philippines
Research Site
Quezon City, Philippines

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jonathan C. Fox, MD	AstraZeneca

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

CSR-D5130C00065.pdf 

D5130C00065_CSP_redacted_17_Oct_2013 

Publications:

Hiasa Y, Teng R, Emanuelsson H. Pharmacodynamics, pharmacokinetics and safety of ticagrelor in Asian patients with stable coronary artery disease. Cardiovasc Interv Ther. 2014 Oct;29(4):324-33. doi: 10.1007/s12928-014-0277-1. Epub 2014 Jun 17.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01118325 History of Changes
Other Study ID Numbers:	D5130C00065
First Posted:	May 6, 2010
Results First Posted:	April 9, 2012
Last Update Posted:	July 8, 2014
Last Verified:	June 2014

Keywords provided by AstraZeneca:

Stable Coronary Artery Disease; Platelet Aggregation

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Clopidogrel	Ticagrelor; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs