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

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 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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Ticagrelor

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118325

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

CSR-D5130C00065.pdf This link exits the ClinicalTrials.gov site

D5130C00065_CSP_redacted_17_Oct_2013 This link exits the ClinicalTrials.gov site

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
Study First Received:	April 30, 2010
Results First Received:	March 14, 2012
Last Updated:	June 24, 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

ClinicalTrials.gov processed this record on September 21, 2017