Non-ST or ST Elevation Acute Coronary SyndromesPhase 4HouYiNCT01864005
A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Non-ST or ST Elevation Acute Coronary Syndromes, run by AstraZeneca at 3 sites in China.
Trial summary
The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ST or ST Elevation Acute Coronary Syndromes
- 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
- 60 participants
- Where
- 3 sitesChina
- Study dates
- May 2013to Mar 2014
- 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
- 1. Provision of informed consent prior to any study specific procedures
- 2. Female or male aged at least 18 years
- 3. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
- 4. Index event of non-ST or ST segment elevation ACS.
Who cannot join
- 1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
- 2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
- 3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
- 4. Requires dialysis
- 5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel With Aspirin as Background Therapy in Chinese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks.
ClopidogrelDrug
75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks.
| 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.
the Percentage Inhibition of the P2Y12 Receptor
Note: the primary endpoint was changed per the statistical analysis plan prior database lock.
Measured: at 2 hours after first dose of study drug
Secondary outcomes (4)
the Percentage Inhibition of the P2Y12 Receptor
Measured: at 0.5 hour after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor
Measured: at 8 hours after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor
Measured: at 24 hours after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor
Measured: at 6 weeks after first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014
- Study completionMar 2014
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 Non-ST or ST Elevation Acute Coronary SyndromesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yundai Chen, Professor, Principal investigator, The General Hospital of People's Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864005
- Sponsor's protocol ID
- D5130L00053
- Acronym
- HouYi
- Status last verified
- Apr 2015
- First submitted
- 24 May 2013
- Last updated
- 15 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel With Aspirin as Background Therapy in Chinese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
- ClinicalTrials.gov ID
- NCT01864005
- Acronym / sponsor ID
- HouYi / D5130L00053
- Keywords
- Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Posted 2 Mar 2015
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 test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (4 listed)
- 1. Provision of informed consent prior to any study specific procedures
- 2. Female or male aged at least 18 years
- 3. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
- 4. Index event of non-ST or ST segment elevation ACS.
Key exclusion criteria (5 listed)
- 1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
- 2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
- 3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
- 4. Requires dialysis
- 5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy 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 |
|---|---|---|
| Ticagrelor90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks. | Drug | Ticagrelor |
| Clopidogrel75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks. | Drug | clopidogrel |
Primary outcome
the Percentage Inhibition of the P2Y12 Receptor
Time frame: at 2 hours after first dose of study drug
Note: the primary endpoint was changed per the statistical analysis plan prior database lock.
4 secondary outcomes
the Percentage Inhibition of the P2Y12 Receptor
Time frame: at 0.5 hour after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor
Time frame: at 8 hours after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor
Time frame: at 24 hours after first dose of study drug
the Percentage Inhibition of the P2Y12 Receptor
Time frame: at 6 weeks after first dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- D5130L00053\_CSR\_SynopsisLink provided by the sponsor.
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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.
Yundai Chen, Professor principal investigator
The General Hospital of People's Liberation Army
3 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 Non-ST or ST Elevation Acute Coronary Syndromes, run by AstraZeneca at 3 sites in China.
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: finished, as of the sponsor's last update on 15 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 2 Mar 2015). 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?
the Percentage Inhibition of the P2Y12 Receptor (time frame: at 2 hours after first dose of study drug). 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 15 May 2015.