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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01118325
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : April 9, 2012
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stable Coronary Artery Disease Drug: ticagrelor Drug: clopidogrel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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 :
  1. AZD6140 (Cmax) at Week 4 [ Time Frame: Week 4 ]
    Maximum plasma AZD6140 concentration

  2. AZD6140 (AUC0-tau) at Week 4 [ Time Frame: Week 4 ]
    Area under the plasma concentration curve of AZD6140 from time zero to dosing interval

  3. AZD6140 (Tmax) at Week 4 [ Time Frame: Week 4 ]
    Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration

  4. AR-C124910XX (Cmax) at Week 4 [ Time Frame: Week 4 ]
    Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118325


Locations
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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
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Study Director: Jonathan C. Fox, MD AstraZeneca
More Information
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Additional Information:

Publications:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01118325    
Other Study ID Numbers: D5130C00065
First Posted: May 6, 2010    Key Record Dates
Results First Posted: April 9, 2012
Last Update Posted: July 8, 2014
Last Verified: June 2014
Keywords provided by AstraZeneca:
Stable Coronary Artery Disease
Platelet Aggregation
Additional relevant MeSH terms:
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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