NCT01118325

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 9, 2012

Completed
Last Updated

July 8, 2014

Status Verified

June 1, 2014

Enrollment Period

11 months

First QC Date

April 30, 2010

Results QC Date

March 14, 2012

Last Update Submit

June 24, 2014

Conditions

Stable Coronary Artery Disease

Keywords

Stable Coronary Artery DiseasePlatelet Aggregation

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (6)

  • AZD6140 (Cmax) at Week 4

    Week 4

  • AZD6140 (AUC0-tau) at Week 4

    Week 4

  • AZD6140 (Tmax) at Week 4

    Week 4

  • AR-C124910XX (Cmax) at Week 4

    Week 4

  • AR-C124910XX (AUC0-tau) at Week 4

    Week 4

  • +1 more secondary outcomes

Study Arms (3)

AZD6140 45 mg bd

EXPERIMENTAL
Drug: ticagrelor

AZD6140 90 mg bd

EXPERIMENTAL
Drug: ticagrelor

Clopidogrel 75 mg od

ACTIVE COMPARATOR
Drug: clopidogrel

Interventions

ticagrelorDRUG

Drug oral treatment

AZD6140 45 mg bdAZD6140 90 mg bd
clopidogrelDRUG

Drug oral treatment

Clopidogrel 75 mg od

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Research Site

Miyaodai, Fukuoka, Japan

Location

Research Site

Sapporo, Hokkaido, Japan

Location

Research Site

Toride-shi, Ibaraki, Japan

Location

Research Site

Kawasaki-shi, Kanagawa, Japan

Location

Research Site

Kyoto, Kyoto, Japan

Location

Research Site

Ōita, Oita Prefecture, Japan

Location

Research Site

Naha, Okinawa, Japan

Location

Research Site

Osaka, Osaka, Japan

Location

Research Site

Kusatsu-shi, Shiga, Japan

Location

Research Site

Komatsushima-shi, Tokushima, Japan

Location

Research Site

Shinagawa-ku, Tokyo, Japan

Location

Research Site

Davao City, Philippines

Location

Research Site

Quezon City, Philippines

Location

Related 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.

    PMID: 24935072BACKGROUND

Related Links

MeSH Terms

Interventions

TicagrelorClopidogrel

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Jonathan C. Fox, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2010

First Posted

May 6, 2010

Study Start

April 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 8, 2014

Results First Posted

April 9, 2012

Record last verified: 2014-06

Locations

JP(11)PH(2)