Unstable Angina PectorisPhase 4NCT03620760
Efficacy and Safety of Low Dose Ticagrelor in Patients With Unstable Angina Pectoris After Coronary Stent Implantation
A Phase 4 study testing Ticagrelor 90 mg, Ticagrelor 45 mg and Aspirin in people with Unstable Angina Pectoris and Coronary Stent Implantation, run by Xiaofan Wu at 1 site in China.
Trial summary
The study is to evaluate efficacy and safety of low dose of ticagrelor therapy for Chinese unstable angina patients treated with non-urgent coronary stent implantation, to examine whether lower dose ticagrelor (45 mg twice-daily) is not inferior to standard dose (90 mg twice-daily) for the prevention of major adverse… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unstable Angina Pectoris, Coronary Stent Implantation
- What is being tested?
- Ticagrelor 90 mg, Ticagrelor 45 mg and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,036 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2018to 31 Dec 2020
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment
- 18 years≤age≤80 years
- Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure
Who cannot join
- Allergy or intolerance to ticagrelor or aspirin
- Need for oral anticoagulation therapy
- Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
- Active bleeding, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days
- High risk of bradyarrhythmias
- Severe liver dysfunction and abnormal renal function
- Patient is a woman who is pregnant or nursing
- Unable or unwilling to give written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaofan Wu
Beijing, Beijing Municipality, 100029
Xiaofan Wu, Master
About this study
Official title: A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Efficacy and Safety of Low Dose Ticagrelor Compared With Standard Dose Ticagrelor in Patients With Unstable Angina Pectoris After Drug Eluting Stent Implantation
The study is to evaluate efficacy and safety of low dose of ticagrelor therapy for Chinese unstable angina patients treated with non-urgent coronary stent implantation, to examine whether lower dose ticagrelor (45 mg twice-daily) is not inferior to standard dose (90 mg twice-daily) for the prevention of major adverse cardiovascular and cerebrovascular events, as well as will reduce the incidence of bleeding during long-term treatment.
Read the detailed description
This is a prospective, single center, randomized, parallel-group trial designed to evaluate the efficacy and safety of low dose ticagrelor on a background of aspirin for patients treated with non-urgent coronary stent implantation. 2036 subjects will be enrolled. All patients will receive treatment with aspirin and a P2Y12 inhibitor for 3 months after the index procedure. At 3 months, eligible patients were then randomly assigned in a 1:1 ratio to receive a standard dose ticagrelor 90 mg bid or a lower dose ticagrelor 45 mg bid in addition to aspirin 100mg. The primary efficacy end points are the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke at 24 months. The primary safety end point is the incidence of PLATO major bleeding at 24 months.
- Being tested
- Ticagrelor 90 mg, Ticagrelor 45 mg, Aspirin
- Keywords
- Unstable Angina, Stent, Ticagrelor, Platelet aggregation, Percutaneous Coronary Intervention, Coronary Artery Disease, Major Adverse Cardiovascular and Cerebrovascular Events, Bleeding Events
- Medical subject headings
- Angina, Unstable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90 mgDrug
Also called AZD6140
Ticagrelor (AZD6140) 90 mg twice daily dose
Ticagrelor 45 mgDrug
Also called AZD6140
Ticagrelor (AZD6140) 45 mg twice daily dose
AspirinDrug
Aspirin 100 mg once daily dose
| Study group | Role | What they receive |
|---|---|---|
| Lower dose ticagrelor | Experimental | Subjects will be treated with ticagrelor 45 mg twice daily in combination with aspirin 100mg once daily. Receives: Drug: Ticagrelor 45 mg; Drug: Aspirin |
| Standard dose ticagrelor | Active comparator | Subjects will be treated with ticagrelor 90 mg twice daily in combination with aspirin 100mg once daily. Receives: Drug: Ticagrelor 90 mg; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event
Participants with death from vascular causes, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke. Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Participants with PLATO major bleeding event including fatal bleeding, intracranial bleeding, intrapericardial bleeding with cardiac tamponade, hypovolemic shock or severe hypotension due to bleeding and requiring pressures or surgery, a decline in the hemoglobin level of 5.0 g per deciliter or more, or the need for transfusion of at least. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 24 months
Secondary outcomes (3)
Any event from the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke
Participants with any event from the composite of cardiovascular death, non-fatal MI, stent thrombosis, coronary revascularization and stroke. ITT analysis of intent for invasive management population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 24 months
All cause death
Participants with all cause death. ITT analysis of whole population. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 24 months
PLATO-defined any bleeding event
Participants with any other bleeding events (minor bleeding or minimal bleeding) as defined by the PLATO. Events were adjudicated by an endpoint committee.
Measured: Randomization up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start7 Aug 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Angina PectorisStudies of the same condition, open and under way.
- 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
- Model description
- Eligible patients were randomly assigned in a 1:1 ratio to receive ticagrelor 90 mg twice daily plus aspirin 100mg once daily or ticagrelor 45 mg twice daily plus aspirin 100mg once daily.
- Masking
- None (open label)
- Enrolment
- 2,036 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaofan Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaofan Wu, Beijing Anzhen Hospital
- Investigators
- Xiaofan Wu, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620760
- Sponsor's protocol ID
- 2018-2-1064
- Status last verified
- Dec 2018
- First submitted
- 5 Aug 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Efficacy and Safety of Low Dose Ticagrelor Compared With Standard Dose Ticagrelor in Patients With Unstable Angina Pectoris After Drug Eluting Stent Implantation
- ClinicalTrials.gov ID
- NCT03620760
- Acronym / sponsor ID
- 2018-2-1064
- Keywords
- Unstable Angina, Stent, Ticagrelor, Platelet aggregation, Percutaneous Coronary Intervention, Coronary Artery Disease, Major Adverse Cardiovascular and Cerebrovascular Events, Bleeding Events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,036 participants (estimated)
- Lead sponsor
- Xiaofan WuUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 Aug 2018 (actual)
- 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.
The study is to evaluate efficacy and safety of low dose of ticagrelor therapy for Chinese unstable angina patients treated with non-urgent coronary stent implantation, to examine whether lower dose ticagrelor (45 mg twice-daily) is not inferior to standard dose (90 mg twice-daily) for the prevention of major adverse cardiovascular and cerebrovascular events, as well as will reduce the incidence of bleeding during long-term treatment.
Detailed description
This is a prospective, single center, randomized, parallel-group trial designed to evaluate the efficacy and safety of low dose ticagrelor on a background of aspirin for patients treated with non-urgent coronary stent implantation. 2036 subjects will be enrolled. All patients will receive treatment with aspirin and a P2Y12 inhibitor for 3 months after the index procedure. At 3 months, eligible patients were then randomly assigned in a 1:1 ratio to receive a standard dose ticagrelor 90 mg bid or a lower dose ticagrelor 45 mg bid in addition to aspirin 100mg. The primary efficacy end points are the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke at 24 months. The primary safety end point is the incidence of PLATO major bleeding at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients were randomly assigned in a 1:1 ratio to receive ticagrelor 90 mg twice daily plus aspirin 100mg once daily or ticagrelor 45 mg twice daily plus aspirin 100mg once daily.
| Arm | Type | Receives |
|---|---|---|
| Lower dose ticagrelor | Experimental | Drug: Ticagrelor 45 mg, Drug: AspirinSubjects will be treated with ticagrelor 45 mg twice daily in combination with aspirin 100mg once daily. |
| Standard dose ticagrelor | Active comparator | Drug: Ticagrelor 90 mg, Drug: AspirinSubjects will be treated with ticagrelor 90 mg twice daily in combination with aspirin 100mg once daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment
- 18 years≤age≤80 years
- Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure
Key exclusion criteria (8 listed)
- Allergy or intolerance to ticagrelor or aspirin
- Need for oral anticoagulation therapy
- Concomitant oral or intravenous therapy with strong inhibitors of Cytochrome P450, family 3, subfamily A (CYP3A), Substrates of CYP3A with narrow therapeutic indices or strong inducers of CYP3A
- Active bleeding, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days
- High risk of bradyarrhythmias
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 |
|---|---|---|
| Ticagrelor 90 mgAlso: AZD6140Ticagrelor (AZD6140) 90 mg twice daily dose | Drug | Standard dose ticagrelor |
| Ticagrelor 45 mgAlso: AZD6140Ticagrelor (AZD6140) 45 mg twice daily dose | Drug | Lower dose ticagrelor |
| AspirinAspirin 100 mg once daily dose | Drug | Lower dose ticagrelor, Standard dose ticagrelor |
Primary outcome
Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event
Time frame: Randomization up to 24 months
Participants with death from vascular causes, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke. Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee. Participants with PLATO major bleeding event including fatal bleeding, intracranial bleeding, intrapericardial bleeding with cardiac tamponade, hypovolemic shock or severe hypotension due to bleeding and requiring pressures or surgery, a decline in the hemoglobin level of 5.0 g per deciliter or more, or the need for transfusion of at least. Events were adjudicated by an endpoint committee.
3 secondary outcomes
Any event from the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, coronary revascularization and stroke
Time frame: Randomization up to 24 months
All cause death
Time frame: Randomization up to 24 months
PLATO-defined any bleeding event
Time frame: Randomization up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Xiaofan Wu study director
Beijing Anzhen Hospital
1 site 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 90 mg, Ticagrelor 45 mg and Aspirin in people with Unstable Angina Pectoris and Coronary Stent Implantation, run by Xiaofan Wu at 1 site 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofan Wu, MD (13370103552, drwuxf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) and major bleeding event (time frame: Randomization up to 24 months). 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 24 Dec 2018.