Stable Coronary Artery DiseasePhase 4NCT01523366

A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

A Phase 4 study testing Ticagrelor and Clopidogrel in people with Stable Coronary Artery Disease, run by AstraZeneca at 5 sites in United States.

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 this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease. Read more about this study

Who is it for?: Ages 18 years and older
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: 53 participants
Where: 5 sitesUnited States
Study dates: Apr 2012to May 2013
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed and dated informed consent before initiation of any study-related procedures
Male or female patients aged 18 years or older Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
Females must be post menopausal or surgically sterile Self-identified as Hispanic

Who cannot join

Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
Current smokers, including the use of tobacco containing products in the past 1 month of randomization
Patients requiring dialysis

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Research Site
Hollywood, Florida
Research Site
Jacksonville, Florida
Research Site
Linden, New Jersey
Research Site
Los Angeles, California
Research Site
Miami, Florida

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Hispanic Patients With Stable Coronary Artery Disease

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.

Read the detailed description

A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease

Conditions: Stable Coronary Artery Disease
Being tested: Ticagrelor, Clopidogrel
Keywords: Stable Coronary Artery Disease, CAD

What participants receive

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

TicagrelorDrug
Min - 90mg/Max - 180mg tablets (loading dose)
ClopidogrelDrug
75mg (once daily)/Max - 600mg tablets (loading dose)

Study groups in NCT01523366
Study group	Role	What they receive
Ticagrelor	Experimental	Not described Receives: Drug: Ticagrelor
Clopidogrel	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 the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value
Measured: At 2 hours after the loading dose

Secondary outcomes (4)

Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose
Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value
Measured: At 0.5 and 8 hours after the loading dose
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8
The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value
Measured: At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.
Measured: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
The SD is a statistic using the log-transformed data and is not the geometric SD.
Measured: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

Timeline

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

Apr 2012May 2013

First posted1 Feb 2012 (estimated)
Study startApr 2012
Primary completionMay 2013
Study completionMay 2013

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 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01523366
Sponsor's protocol ID: D5130L00012
Status last verified: Aug 2014
First submitted: 30 Jan 2012
Last updated: 18 Aug 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 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Hispanic Patients With Stable Coronary Artery Disease
ClinicalTrials.gov ID: NCT01523366
Acronym / sponsor ID: D5130L00012
Conditions: Stable Coronary Artery Disease
Keywords: Stable Coronary Artery Disease, CAD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 1 Feb 2012 (estimated)
Results: Posted 5 Aug 2014

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 this study is to assess the pharmacodynamic effect of ticagrelor in Hispanic patients with stable coronary artery disease.

Detailed description

A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in Hispanic Patients with Stable Coronary Artery Disease

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ticagrelor	Experimental	Drug: Ticagrelor
Clopidogrel	Active comparator	Drug: Clopidogrel

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Provision of signed and dated informed consent before initiation of any study-related procedures
Male or female patients aged 18 years or older Documented stable CAD fulfilling and taking 75-100mg ASA daily treatment
Females must be post menopausal or surgically sterile Self-identified as Hispanic

Key exclusion criteria (4 listed)

Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve) or dual antiplatelet treatment (e.g., clopidogrel, prasugrel, ASA dose other than 75 to 100 mg daily) during study period
Patients who had ACS or stent placed within 12 months of screening Patients with a history of moderate or severe hepatic impairment
Current smokers, including the use of tobacco containing products in the past 1 month of randomization
Patients requiring dialysis

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
TicagrelorMin - 90mg/Max - 180mg tablets (loading dose)	Drug	Ticagrelor
Clopidogrel75mg (once daily)/Max - 600mg tablets (loading dose)	Drug	Clopidogrel

Primary outcome

Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose
Time frame: At 2 hours after the loading dose
Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value

4 secondary outcomes

Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose
Time frame: At 0.5 and 8 hours after the loading dose
Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8
Time frame: At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8
Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses
Time frame: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose
AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses
Time frame: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose

Results and safety

Results posted to the registry on 5 Aug 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 (Period 1) Then Clopidogrel (Period 2) Sequence	20	19
Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence	20	20

Primary outcome: Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose

Time frame: At 2 hours after the loading dose. Least squares mean (95% Confidence Interval). Unit: PRU

Measure	Ticagrelor Arm n = 37	Clopidogrel Arm n = 34
Value	34.2 (12.4 to 55.9)	201.4 (178.7 to 224.1)

Ticagrelor Arm vs Clopidogrel Arm: Mean Difference (Final Values): -167.2 (95% CI -197.0 to -137.4), p <.001, Mixed Models Analysis

Population analysed: Pharmacodynamic (PD) Analysis Set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of signature of the informed consent throughout the treatment period including the follow up visit (approximately 11 weeks for each participant).. Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ticagrelor Arm	0 of 40 (0%)	5 of 40 (12.5%)	Not reported
Clopidogrel Arm	0 of 39 (0%)	6 of 39 (15.4%)	Not reported

Limitations and caveats (from the sponsor): Total N for the secondary outcome analysis after multiple doses and for PK measures was not the same for 2 hours, 8 hours and end of dosing. Only the first time point total N can be reported via the form. Row titles indicate N's where they differ.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
D5130L00012\_Clinical\_Study\_Protocol\_RedactedLink provided by the sponsor.
CSR\_SynopsisLink provided by the sponsor.

Related trials for Stable Coronary Artery Disease

Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
RecruitingPhase 3
Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
RecruitingPhase 4
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Not yet recruitingPhase 2
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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.

Glenn Carlson, MD study director

AstraZeneca PharmaceuticalsRoom C3B-718PO Box 15437Wilmington, DE 19850-5437 USA

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor and Clopidogrel in people with Stable Coronary Artery Disease, run by AstraZeneca at 5 sites in United States.

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 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 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Aug 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?

Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose (time frame: At 2 hours after the loading dose). 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 NCT01523366.

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 18 Aug 2014.