Acute Coronary SyndromePhase 3NCT01294462

Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)

A Phase 3 study testing Ticagrelor, Clopidogrel and Acetylsalicylic acid ASA in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by AstraZeneca at 87 sites in 3 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 assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI). Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Acute Coronary Syndrome, Percutaneous Coronary Intervention
What is being tested?: Ticagrelor, Clopidogrel and Acetylsalicylic acid ASA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 801 participants
Where: 87 sitesin 3 countries
Study dates: Feb 2011to Jul 2012
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed informed consent
Index event of non-ST or ST segment elevation ACS

Who cannot join

Index event is an acute complication of percutaneous coronary intervention
Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
Oral anticoagulation therapy that cannot be stopped
The conditions associated with increased risk of bradycardiac events

Trial locations and contacts

87 sites in 3 countries.

Country

City, postcode or hospital

87 sites in 3 countries

Japan79 sites

Research Site
Adachi-ku, Tokyo
Research Site
Ageo-shi, Saitama
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Akashi-shi, Hyōgo
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Akita, Akita
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Amagasaki-shi, Hyōgo
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Atsugi-shi, Kanagawa
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Azumino-shi, Nagano
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Bunkyo, Tokyo
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Bunkyo-ku, Tokyo
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Chiyoda-ku, Tokyo
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Chuo-shi, Yamanashi
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Fukui-shi, Fukui
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Fukuoka, Fukuoka
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Gifu, Gifu
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Hakusan-shi, Ishikawa-ken
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Hamamatsu, Shizuoka
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Hidaka, Saitama
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Higashiibaragi-gun, Ibaragi
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Hirakata, Osaka
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Ichihara-shi, Chiba
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Ichinomiya-shi, Aichi-ken
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Isehara, Kanagawa
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Isesaki, Gunma
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Izunokuni, Shizuoka
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Kamakura-shi, Kanagawa
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Kamogawa-shi, Chiba
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Kanazawa, Ishikawa-ken
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Kasuya-gun, Fukuoka
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Kawachinagano-shi, Osaka
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Kawanishi-shi, Hyōgo
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Kawasaki-shi, Kanagawa
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Kisarazu-shi, Chiba
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Kobe, Hyōgo
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Komatsushima-shi, Tokushima
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Kumamoto, Kumamoto
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Kurashiki, Okayama-ken
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Kure, Hiroshima
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Kurume, Fukuoka
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Kusatsu-shi, Shiga
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Kyoto, Kyoto
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Maebashi, Gunma
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Matsue, Shimane
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Matsuyama, Ehime
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Meguro City, Tokyo
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Moriyama, Shiga
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Nagasaki, Nagasaki
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Nagoya, Aichi-ken
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Nankoku-shi, Kochi
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Nishinomiya, Hyōgo
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Ōita, Oita Prefecture
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Okayama, Okayama-ken
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Okazaki-shi, Aichi-ken
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Ome-shi, Tokyo
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Osaka, Osaka
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Saga, Saga-ken
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Sagamihara-shi, Kanagawa
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Sakai-shi, Osaka
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Sakaide-shi, Kagawa-ken
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Sapporo, Hokkaido
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Sashima-gun, Ibaragi
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Sayama-shi, Saitama
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Sendai, Miyagi
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Shimada-shi, Shizuoka
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Shinagawa-ku, Tokyo
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Shinjuku, Tokyo
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Suginami-ku, Tokyo
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Sunto-gun, Shizuoka
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tabashi City, Tokyo
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Takarazuka-shi, Hyōgo
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Takasaki-shi, Gunma
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Tanabe-shi, Wakayama
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Tokushima, Tokushima
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Toyohashi, Aichi-ken
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Toyota-shi, Aichi-ken
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Ueda-shi, Nagano
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Wakayama, Wakayama
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Yamato-shi, Kanagawa
Research Site
Yatsushiro, Kumamoto
Research Site
Yokohama, Kanagawa

Other trials in Japan

South Korea4 sites

Research Site
Cheonan, Chungcheongnam-do
Research Site
Daejeon
Research Site
Incheon
Research Site
Seoul

Other trials in South Korea

Taiwan4 sites

Research Site
Kweishan Shiang, Taoyuan Hsien
Research Site
Niao-song-shiang, Kaohsiung
Research Site
Taichung
Research Site
Taipei

Other trials in Taiwan

About this study

Official title: A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes(ACS) for Whom PCI is Planned

Conditions: Acute Coronary Syndrome, Percutaneous Coronary Intervention
Being tested: Ticagrelor, Clopidogrel, Acetylsalicylic acid ASA
Keywords: acute coronary syndrome, coronary disease, coronary artery disease
Medical subject headings: Acute Coronary Syndrome, Coronary Disease, Coronary Artery Disease

What participants receive

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

TicagrelorDrug
Also called AZD6140
90 mg, oral dose twice daily
ClopidogrelDrug
Also called Plavix
75 mg, oral dose once daily
Acetylsalicylic acid ASADrug
Low Dose ASA

Study groups in NCT01294462
Study group	Role	What they receive
1	Experimental	Ticagrelor (AZD6140) Receives: Drug: Ticagrelor; Drug: Acetylsalicylic acid ASA
2	Active comparator	Clopidogrel Receives: Drug: Clopidogrel; Drug: Acetylsalicylic acid ASA

What is being measured

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

Major Bleeding
Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Measured: Ongoing up to12 months
Major Adverse Cardiac Events (MACE)
Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Measured: Ongoing up to 12 months

Secondary outcomes (2)

Major and Minor Bleeding
Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Measured: Ongoing up to12 months
Composite of All-cause Mortality, MI or Stroke
Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Measured: Ongoing up to 12 months

Timeline

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

Feb 2011Jul 2012

First posted11 Feb 2011 (estimated)
Study startFeb 2011
Primary completionJul 2012
Study completionJul 2012

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.
Other trials for Acute Coronary SyndromeStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 801 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01294462
Sponsor's protocol ID: D5130C00027
Status last verified: May 2014
First submitted: 10 Feb 2011
Last updated: 27 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes(ACS) for Whom PCI is Planned
ClinicalTrials.gov ID: NCT01294462
Acronym / sponsor ID: D5130C00027
Conditions: Acute Coronary Syndrome, Percutaneous Coronary Intervention
Keywords: acute coronary syndrome, coronary disease, coronary artery disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 801 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 11 Feb 2011 (estimated)
Results: Posted 2 May 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Ticagrelor, Drug: Acetylsalicylic acid ASATicagrelor (AZD6140)
2	Active comparator	Drug: Clopidogrel, Drug: Acetylsalicylic acid ASAClopidogrel

Who may qualify

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

Key inclusion criteria (2 listed)

Provision of signed informed consent
Index event of non-ST or ST segment elevation ACS

Key exclusion criteria (4 listed)

Index event is an acute complication of percutaneous coronary intervention
Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
Oral anticoagulation therapy that cannot be stopped
The conditions associated with increased risk of bradycardiac events

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
TicagrelorAlso: AZD614090 mg, oral dose twice daily	Drug	1
ClopidogrelAlso: Plavix75 mg, oral dose once daily	Drug	2
Acetylsalicylic acid ASALow Dose ASA	Drug	1, 2

Primary outcome

Major Bleeding
Time frame: Ongoing up to12 months
Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Major Adverse Cardiac Events (MACE)
Time frame: Ongoing up to 12 months
Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.

2 secondary outcomes

Major and Minor Bleeding
Time frame: Ongoing up to12 months
Composite of All-cause Mortality, MI or Stroke
Time frame: Ongoing up to 12 months

Results and safety

Results posted to the registry on 2 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ticagrelor (AZD6140)	401	335
Clopidogrel	400	337

Primary outcome: Major Bleeding

Time frame: Ongoing up to12 months. Number. Unit: Percent probability

Measure	Ticagrelor (AZD6140) n = 387	Clopidogrel n = 380
Value	11.2	8.4

Ticagrelor (AZD6140) vs Clopidogrel: Hazard Ratio (HR): 1.54 (95% CI 0.94 to 2.53), Regression, Cox

Population analysed: Safety analysis set which includes all patients who received randomized treatment with available post-treatment safety data

Primary outcome: Major Adverse Cardiac Events (MACE)

Time frame: Ongoing up to 12 months. Number. Unit: Percent probability

Measure	Ticagrelor (AZD6140) n = 400	Clopidogrel n = 400
Value	10.2	8.1

Ticagrelor (AZD6140) vs Clopidogrel: Hazard Ratio (HR): 1.47 (95% CI 0.88 to 2.44), Regression, Cox

Population analysed: Full Analysis set which includes all randomized patients with available post-randomization efficacy data

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 6 months to 1 year.. Other adverse events reported at 1.8% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ticagrelor (AZD6140)	92 of 387 (23.8%)	327 of 387 (84.5%)	Not reported
Clopidogrel	112 of 380 (29.5%)	337 of 380 (88.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSR-D5130C00027.pdfLink provided by the sponsor.

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Recruiting
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Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
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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.

Judith Hsia, MD study director

AstraZeneca

87 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 4 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Japan, South Korea, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 2 May 2014). 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?

Major Bleeding (time frame: Ongoing up to12 months). The study lists 2 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 NCT01294462.

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 27 Jun 2014.