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

Stable Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118325
• Other study ID #: D5130C00065
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2010
• Last updated: June 24, 2014
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfarePhilippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Coronary Artery Disease

Intervention

Drug:
• ticagrelor
Drug oral treatment
• clopidogrel
Drug oral treatment

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Japan,  Philippines, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients	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.	Week 4	No
Primary	IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients	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.	Week 4	No
Primary	IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients	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.	Week 4	No
Primary	IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients	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.	Week 4	No
Primary	IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients	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.	Week 4	No
Secondary	AZD6140 (Cmax) at Week 4	Maximum plasma AZD6140 concentration	Week 4	No
Secondary	AZD6140 (AUC0-tau) at Week 4	Area under the plasma concentration curve of AZD6140 from time zero to dosing interval	Week 4	No
Secondary	AZD6140 (Tmax) at Week 4	Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration	Week 4	No
Secondary	AR-C124910XX (Cmax) at Week 4	Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX	Week 4	No
Secondary	AR-C124910XX (AUC0-tau) at Week 4	Area under the plasma concentration curve of AZD6140 drug metabolite AR-C124910XX from time zero to dosing interval	Week 4	No
Secondary	AR-C124910XX (Tmax) at Week 4	Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration	Week 4	No

External Links

•   Link
•   CSR-D5130C00065.pdf
•   D5130C00065_CSP_redacted_17_Oct_2013