Coronary Heart DiseasePhase 3NCT01757262
A Clinical Study of Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patient
A Phase 3 study testing 90 mg Ticagrelor and 75mg Clopidogrel in people with Coronary Heart Disease, run by AstraZeneca.
Trial summary
Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- 90 mg Ticagrelor and 75mg Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male or female Vietnamese patients (as confirmed by the Principal Investigator) aged >18 years with suitable veins for cannulations or repeated venipunctures and stable coronary heart disease
- Stable use of aspirin 75 to 100 mg daily for at least the preceding 2 weeks and which will be continued throughout the study period
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive
- Women must have a negative urine pregnancy test at Visit 1
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
- Unstable angina or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
- Patients who had acute coronary syndrome or stent placed within 12 months of screening
- Planned arterial revascularization
- Current use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole or cilostazol
About this study
Official title: Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients With Coronary Heart Disease: A Randomized, Open Label, Crossover Study
Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel
Read the detailed description
Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients with Coronary Heart Disease: A Randomized, Open Label, Crossover Study
- Conditions
- Coronary Heart Disease
- Being tested
- 90 mg Ticagrelor, 75mg Clopidogrel
- Keywords
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90 mg TicagrelorDrug
Morning and Evening dose for 5 days
75mg ClopidogrelDrug
Morning dose for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Ticagrelor | Experimental | 90 mg Ticagrelor Receives: Drug: 90 mg Ticagrelor |
| Clopidogrel | Active comparator | 75mg Clopidogrel Receives: Drug: 75mg Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
Measured: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
Measured: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
Secondary outcomes (1)
Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables
Measured: From screening to followup (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart 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 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nguyen Lan Viet, MD, Principal investigator, National Heart Institute, Bach Mai Hospital, VietnamJudith Hsia, MD, Study director, Astrazeneca, Wilmington, USMiriana Kujacic, MD, Study chair, Astrazeneca, Molndal, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757262
- Sponsor's protocol ID
- D5130C00078
- Status last verified
- May 2013
- First submitted
- 21 Dec 2012
- Last updated
- 13 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients With Coronary Heart Disease: A Randomized, Open Label, Crossover Study
- ClinicalTrials.gov ID
- NCT01757262
- Acronym / sponsor ID
- D5130C00078
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 28 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study in Vietnamese Patients with Coronary Heart Disease to investigate safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel
Detailed description
Safety and P2Y12 Receptor Inhibition Effects of Ticagrelor and Clopidogrel in Vietnamese Patients with Coronary Heart Disease: A Randomized, Open Label, Crossover Study
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor | Experimental | Drug: 90 mg Ticagrelor90 mg Ticagrelor |
| Clopidogrel | Active comparator | Drug: 75mg Clopidogrel75mg Clopidogrel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female Vietnamese patients (as confirmed by the Principal Investigator) aged >18 years with suitable veins for cannulations or repeated venipunctures and stable coronary heart disease
- Stable use of aspirin 75 to 100 mg daily for at least the preceding 2 weeks and which will be continued throughout the study period
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive
- Women must have a negative urine pregnancy test at Visit 1
Key exclusion criteria (5 listed)
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
- Unstable angina or any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
- Patients who had acute coronary syndrome or stent placed within 12 months of screening
- Planned arterial revascularization
- Current use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole or cilostazol
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 |
|---|---|---|
| 90 mg TicagrelorMorning and Evening dose for 5 days | Drug | Ticagrelor |
| 75mg ClopidogrelMorning dose for 5 days | Drug | Clopidogrel |
Primary outcome
Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
Time frame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
Pharmacodynamics of Clopidogrel P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)]
Time frame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5
1 secondary outcome
Safety profile in terms of adverse events, blood pressure, pulse, ECG (Electrocardiogram), physical examination, and safety laboratory variables
Time frame: From screening to followup (8 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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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.
Nguyen Lan Viet, MD principal investigator
National Heart Institute, Bach Mai Hospital, Vietnam
Judith Hsia, MD study director
Astrazeneca, Wilmington, US
Miriana Kujacic, MD study chair
Astrazeneca, Molndal, Sweden
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 90 mg Ticagrelor and 75mg Clopidogrel in people with Coronary Heart Disease, run by AstraZeneca.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pharmacodynamics of Ticagrelor on P2Y12 receptor blockade measured by the VerifyNow P2Y12 assay[expressed as P2Y12 reaction units (PRU)] (time frame: Day 1 pre-dose and at 0 (pre-dose), 1, 2, 8, 12 and 24 hours post morning dose on Day 5). 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?
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 13 May 2013.