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Completed

NCT Number: NCT01118325

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

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.

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Key information

Conditions

Stable Coronary Artery Disease

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Miyaodai, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

Drug oral treatment

clopidogrel

Drug

Drug oral treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 6, 2010
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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