An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Stable Coronary Artery Disease |
Drug: ticagrelor Drug: clopidogrel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]Maximum plasma AZD6140 concentration
- AZD6140 (AUC0-tau) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]Area under the plasma concentration curve of AZD6140 from time zero to dosing interval
- AZD6140 (Tmax) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration
- AR-C124910XX (Cmax) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX
- AR-C124910XX (AUC0-tau) at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration
| Enrollment: | 146 |
| Study Start Date: | April 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01118325 History of Changes |
| Other Study ID Numbers: | D5130C00065 |
| Study First Received: | April 30, 2010 |
| Results First Received: | March 14, 2012 |
| Last Updated: | June 24, 2014 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare Philippines: Bureau of Food and Drugs |
Keywords provided by AstraZeneca:
|
Stable Coronary Artery Disease Platelet Aggregation |
Additional relevant MeSH terms:
|
Coronary Artery Disease Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases Ticagrelor |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Purinergic Agents Purinergic Antagonists Purinergic P2 Receptor Antagonists Purinergic P2Y Receptor Antagonists |
ClinicalTrials.gov processed this record on March 03, 2015