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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01118325
First received: April 30, 2010
Last updated: June 24, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


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 ] [ 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.



Secondary Outcome Measures:
  • 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
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:
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
Clopidogrel
Ticagrelor
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014