Clinical trial NCT01118325: An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stable Coronary Artery Disease
Keywords: Stable Coronary Artery Disease
Platelet Aggregation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-06
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients
timeFrame: Week 4
measure: IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients
timeFrame: Week 4
measure: IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients
timeFrame: Week 4
measure: IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients
timeFrame: Week 4
measure: IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients
timeFrame: Week 4
Secondary outcomes:
measure: AZD6140 (Cmax) at Week 4
timeFrame: Week 4
measure: AZD6140 (AUC0-tau) at Week 4
timeFrame: Week 4
measure: AZD6140 (Tmax) at Week 4
timeFrame: Week 4
measure: AR-C124910XX (Cmax) at Week 4
timeFrame: Week 4
measure: AR-C124910XX (AUC0-tau) at Week 4
timeFrame: Week 4
measure: AR-C124910XX (Tmax) at Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: Mizumaki
country: Japan
facility: Research Site
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Toride-shi
country: Japan
facility: Research Site
state: Ibaraki
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto
city: Naha-shi
country: Japan
facility: Research Site
state: Okinawa
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Kusatsu-shi
country: Japan
facility: Research Site
state: Shiga
city: Komatsushima-shi
country: Japan
facility: Research Site
state: Tokushima
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Oita
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Jonathan C. Fox, MD
role: STUDY_DIRECTOR
References:
citation: 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.