Stable Coronary Artery DiseasePhase 2NCT01118325

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

A Phase 2 study testing ticagrelor and clopidogrel in people with Stable Coronary Artery Disease, run by AstraZeneca at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Stable Coronary Artery Disease
What is being tested?: ticagrelor and clopidogrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 13 sitesin 2 countries
Study dates: Apr 2010to Mar 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

13 sites in 2 countries.

Country

City, postcode or hospital

13 sites in 2 countries

Japan11 sites

Research Site
Kawasaki-shi, Kanagawa
Research Site
Komatsushima-shi, Tokushima
Research Site
Kusatsu-shi, Shiga
Research Site
Kyoto, Kyoto
Research Site
Miyaodai, Fukuoka
Research Site
Naha, Okinawa
Research Site
Ōita, Oita Prefecture
Research Site
Osaka, Osaka
Research Site
Sapporo, Hokkaido
Research Site
Shinagawa-ku, Tokyo
Research Site
Toride-shi, Ibaraki

Other trials in Japan

Philippines2 sites

Research Site
Davao City
Research Site
Quezon City

Other trials in Philippines

About this study

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

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.

Conditions: Stable Coronary Artery Disease
Being tested: ticagrelor, clopidogrel
Keywords: Stable Coronary Artery Disease, Platelet Aggregation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ticagrelorDrug
Drug oral treatment
clopidogrelDrug
Drug oral treatment

Study groups in NCT01118325
Study group	Role	What they receive
AZD6140 45 mg bd	Experimental	Not described Receives: Drug: ticagrelor
AZD6140 90 mg bd	Experimental	Not described Receives: Drug: ticagrelor
Clopidogrel 75 mg od	Active comparator	Not described Receives: Drug: clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4

Secondary outcomes (6)

AZD6140 (Cmax) at Week 4
Maximum plasma AZD6140 concentration
Measured: Week 4
AZD6140 (AUC0-tau) at Week 4
Area under the plasma concentration curve of AZD6140 from time zero to dosing interval
Measured: Week 4
AZD6140 (Tmax) at Week 4
Time to reach peak or maximum concentration of AZD6140 following AZD6140 administration
Measured: Week 4
AR-C124910XX (Cmax) at Week 4
Maximum plasma concentration of AZD6140 drug metabolite AR-C124910XX
Measured: Week 4
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
Measured: Week 4
AR-C124910XX (Tmax) at Week 4
Time to reach peak or maximum concentration of AZD6140 drug metabolite AR-C124910XX following AZD6140 administration
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Mar 2011

First posted6 May 2010 (estimated)
Study startApr 2010
Primary completionMar 2011
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01118325
Sponsor's protocol ID: D5130C00065
Status last verified: Jun 2014
First submitted: 30 Apr 2010
Last updated: 8 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 24935072

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
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Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation
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All Stable Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01118325
Acronym / sponsor ID: D5130C00065
Conditions: Stable Coronary Artery Disease
Keywords: Stable Coronary Artery Disease, Platelet Aggregation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 6 May 2010 (estimated)
Results: Posted 9 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
AZD6140 45 mg bd	Experimental	Drug: ticagrelor
AZD6140 90 mg bd	Experimental	Drug: ticagrelor
Clopidogrel 75 mg od	Active comparator	Drug: clopidogrel

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ticagrelorDrug oral treatment	Drug	AZD6140 45 mg bd, AZD6140 90 mg bd
clopidogrelDrug oral treatment	Drug	Clopidogrel 75 mg od

Primary outcome

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.
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.
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.
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.
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.

6 secondary outcomes

AZD6140 (Cmax) at Week 4
Time frame: Week 4
AZD6140 (AUC0-tau) at Week 4
Time frame: Week 4
AZD6140 (Tmax) at Week 4
Time frame: Week 4
AR-C124910XX (Cmax) at Week 4
Time frame: Week 4
AR-C124910XX (AUC0-tau) at Week 4
Time frame: Week 4
AR-C124910XX (Tmax) at Week 4
Time frame: Week 4

Results and safety

Results posted to the registry on 9 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD6140 45 mg bd	50	49
AZD6140 90 mg bd	43	43
Clopidogrel 75 mg od	46	45

Primary outcome: Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients

Time frame: Week 4. Mean (Standard Deviation). Unit: percentage inhibition

Measure	AZD6140 45 mg bd n = 41	AZD6140 90 mg bd n = 36	Clopidogrel 75 mg od n = 39
Value	64.5 (14.8)	73.0 (14.2)	38.9 (20.7)

Population analysed: Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan

Primary outcome: IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients

Time frame: Week 4. Mean (Standard Deviation). Unit: percentage inhibition

Measure	AZD6140 45 mg bd n = 41	AZD6140 90 mg bd n = 36	Clopidogrel 75 mg od n = 39
Value	67.3 (15.6)	73.2 (15.1)	43.7 (20.6)

Population analysed: Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan

Primary outcome: IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients

Time frame: Week 4. Mean (Standard Deviation). Unit: percentage inhibition

Measure	AZD6140 45 mg bd n = 41	AZD6140 90 mg bd n = 36	Clopidogrel 75 mg od n = 39
Value	62.7 (17.7)	68.6 (16.0)	42.5 (20.2)

Population analysed: Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan

Primary outcome: IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients

Time frame: Week 4. Mean (Standard Deviation). Unit: percentage inhibition

Measure	Arm 1 - AZD6140 45 mg bd n = 41	AZD6140 90 mg bd n = 36	Clopidogrel 75 mg od n = 39
Value	56.9 (20.9)	66.8 (20.1)	41.8 (21.7)

Population analysed: Only Japanese participants who had IPA data at Week 4 were considered in this analysis. Arm AZD6140 90 mg bd includes one non-Japanese participant resident in Japan

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD6140 45 mg bd	2 of 50 (4%)	13 of 50 (26%)	Not reported
AZD6140 90 mg bd	1 of 43 (2.3%)	23 of 43 (53.5%)	Not reported
Clopidogrel 75 mg od	0 of 46 (0%)	9 of 46 (19.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24935072Hiasa 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.
Related InfoLink provided by the sponsor.
CSR-D5130C00065.pdfLink provided by the sponsor.
D5130C00065\_CSP\_redacted\_17\_Oct\_2013Link provided by the sponsor.

Related trials for Stable Coronary Artery Disease

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
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Recruiting
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Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jonathan C. Fox, MD study director

AstraZeneca

13 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ticagrelor and clopidogrel in people with Stable Coronary Artery Disease, run by AstraZeneca at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Japan, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients (time frame: Week 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01118325, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.