An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease
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ClinicalTrials.gov Identifier: NCT01118325 |
Recruitment Status :
Completed
First Posted : May 6, 2010
Results First Posted : April 9, 2012
Last Update Posted : July 8, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stable Coronary Artery Disease | Drug: ticagrelor Drug: clopidogrel | Phase 2 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118325
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 |
Study Director: | Jonathan C. Fox, MD | AstraZeneca |
Publications:
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01118325 |
Other Study ID Numbers: |
D5130C00065 |
First Posted: | May 6, 2010 Key Record Dates |
Results First Posted: | April 9, 2012 |
Last Update Posted: | July 8, 2014 |
Last Verified: | June 2014 |
Stable Coronary Artery Disease Platelet Aggregation |
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 |