Acute Coronary SyndromeNCT04338919
Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI
A study testing Percutaneous coronary intervention and Ticagrelor plus aspirin in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Fujian Medical University at 1 site in China.
Trial summary
The study is to evaluate the effect of optimized 12-month step-down antiplatelet therapy (APT) compared with standard 12-month dual antiplatelet therapy in clinical net adverse events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous coronary intervention and Ticagrelor plus aspirin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,020 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2020to 1 Apr 2023
- Phase
- Interventional
- 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
- Enrollment into the study will require meeting at least one of these clinical syndromes.
- Unstable angina
- Non-ST elevation myocardial infarction (NSTEMI)
- ST elevation MI (STEMI)
- Non predominant coronary artery disease, it is defined as: exclusion of left main artery disease or left main artery bifurcated disease or ostial left anterior descending disease by coronary angiography imaging, and other high-risk vascular diseases considered by surgeons
- Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure
Who cannot join
- Complications during stenting for coronary artery disease
- Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula
- Any planned surgery within 6 months
- any reason why any antiplatelet therapy might need to be discontinued within 12 months
- Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 15ml/min/1.73m^2
- Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants)
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- Platelet count < 100,000 mm^3
- Contraindication to aspirin
- Contraindication to ticagrelor
- Liver cirrhosis
- Women of child-bearing potential
- Life expectancy < 1 year
- Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Union Hospital, Fujian Medical University
Fuzhou, Fujian, 350001
Lianglong Chen, PhD, MD, (0086)139-5030-3022, lianglongchen@126.com
Lianglong Chen, MD,PhD
About this study
Official title: A Prospective, Randomised, Open-labeled, Parallel Group Study to Assess the Effect of Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI
The study is to evaluate the effect of optimized 12-month step-down antiplatelet therapy (APT) compared with standard 12-month dual antiplatelet therapy in clinical net adverse events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome (ACS) who are not the predominant coronary artery disease after percutaneous coronary intervention (PCI).
Read the detailed description
This is a prospective, multi- center, randomized, parallel-group trial designed to evaluate the effect of optimized 12-month step-down antiplatelet therapy compared with standard 12-month dual antiplatelet therapy in clinical net adverse clinical events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome who are not the main coronary artery disease.2020 subjects will be enrolled. After PCI,eligible patients will be randomly assigned in a 1:1 ratio to either the optimized antiplatelet therapy group（O-APT）or the standard antiplatelet therapy group（S-APT）. The primary efficacy end points are clinical net adverse clinical events ,or the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, ischemia driven coronary revascularization and stroke at 12 months. The primary safety end point is the incidence of PLATO major bleeding or Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 12 months.
- Being tested
- Percutaneous coronary intervention, Ticagrelor plus aspirin
- Keywords
- antiplatelet therapy, Non-predominant coronary artery disease, Ticagrelor, aspirin
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
Also called PCI
PCI with stent implantation
Ticagrelor plus aspirinDrug
Ticagrelor plus aspirin
| Study group | Role | What they receive |
|---|---|---|
| O-APT group | Experimental | Ticagrelor 90 mg twice daily plus aspirin 100mg once daily in the first month, Ticagrelor 90mg bid between the second and the sixth months Ticagrelor 45mg bid between the seventh and the twelfth months Receives: Procedure: Percutaneous coronary intervention; Drug: Ticagrelor plus aspirin |
| S-APT group | Active comparator | ticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months Receives: Procedure: Percutaneous coronary intervention; Drug: Ticagrelor plus aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular and cerebrovascular adverse events
Participants with death from cardiovascular causes, non-fatal myocardial infarction, stent thrombosis,Ischemia driven coronary revascularization and ischemic stroke.Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Measured: Up to 12 months after PCI
Major bleeding events
Plato massive hemorrhage events, including fatal hemorrhage, intracranial hemorrhage, pericardial hemorrhage with pericardial tamponade, hypovolemic shock or severe hypotension caused by hemorrhage, requiring pressor or surgery, hemoglobin level dropping 5.0 g or more per deciliter, or at least requiring blood transfusion. Events were adjudicated by an endpoint committee.
BARC type 2, 3 or 5 bleeding. Events were adjudicated by an endpoint committee.
Measured: Up to 12 months after PCI
The net adverse clinical events
included major adverse cardiovascular and cerebrovascular events or major bleeding events.
Measured: Up to 12 months after PCI
Secondary outcomes (4)
Participants with myocardial infarction (MI) event.
Number of participants with MI event. Events were adjudicated by an endpoint committee.
Measured: Up to 36 months after PCI
Participants with death from cardiovascular causes.
Number of participants with death from cardiovascular causes. Events were adjudicated by an endpoint committee.
Measured: Up to 36 months after PCI
Participants with death from any cause.
Number of participants with death from any cause. Events were adjudicated by an endpoint committee.
Measured: Up to 36 months after PCI
PLATO-defined any bleeding event.
Number of participants with any other bleeding events (minor bleeding or minimal bleeding) as defined by the PLATO. Events were adjudicated by an endpoint committee.
Measured: Up to 36 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start14 Apr 2020
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Fujian Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lianglong Chen, Fujian Medical University
- Investigators
- Chen Lianglong, MD, PhD, Principal investigator, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338919
- Sponsor's protocol ID
- Optimized-APT
- Status last verified
- May 2020
- First submitted
- 28 Mar 2020
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 May 2020. 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 Effect of Optimized Antiplatelet Therapy on the Prognosis of ACS Patients With Non-predominant Coronary Artery Disease After PCI
- ClinicalTrials.gov ID
- NCT04338919
- Acronym / sponsor ID
- Optimized-APT
- Keywords
- antiplatelet therapy, Non-predominant coronary artery disease, Ticagrelor, aspirin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,020 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 8 Apr 2020 (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 the effect of optimized 12-month step-down antiplatelet therapy (APT) compared with standard 12-month dual antiplatelet therapy in clinical net adverse events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome (ACS) who are not the predominant coronary artery disease after percutaneous coronary intervention (PCI).
Detailed description
This is a prospective, multi- center, randomized, parallel-group trial designed to evaluate the effect of optimized 12-month step-down antiplatelet therapy compared with standard 12-month dual antiplatelet therapy in clinical net adverse clinical events, cardiovascular and cerebrovascular adverse events and reducing clinical related bleeding events in the patients with acute coronary syndrome who are not the main coronary artery disease.2020 subjects will be enrolled. After PCI,eligible patients will be randomly assigned in a 1:1 ratio to either the optimized antiplatelet therapy group（O-APT）or the standard antiplatelet therapy group（S-APT）. The primary efficacy end points are clinical net adverse clinical events ,or the event rate of the composite of cardiovascular death, non-fatal myocardial infarction, stent thrombosis, ischemia driven coronary revascularization and stroke at 12 months. The primary safety end point is the incidence of PLATO major bleeding or Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O-APT group | Experimental | Procedure: Percutaneous coronary intervention, Drug: Ticagrelor plus aspirinTicagrelor 90 mg twice daily plus aspirin 100mg once daily in the first month, Ticagrelor 90mg bid between the second and the sixth months Ticagrelor 45mg bid between the seventh and the twelfth months |
| S-APT group | Active comparator | Procedure: Percutaneous coronary intervention, Drug: Ticagrelor plus aspirinticagrelor 90 mg twice daily plus aspirin 100mg once daily for 12 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients admission for coronary artery disease treatment with non-emergency percutaneous intervention with stent deployment
- Enrollment into the study will require meeting at least one of these clinical syndromes.
- Non predominant coronary artery disease, it is defined as: exclusion of left main artery disease or left main artery bifurcated disease or ostial left anterior descending disease by coronary angiography imaging, and other high-risk vascular diseases considered by surgeons
- Patients understands the study requirements and the treatment procedures and provided informed consent before the procedure
Key exclusion criteria (13 listed)
- Complications during stenting for coronary artery disease
- Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula
- Any planned surgery within 6 months
- any reason why any antiplatelet therapy might need to be discontinued within 12 months
- Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) < 15ml/min/1.73m^2
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 |
|---|---|---|
| Percutaneous coronary interventionAlso: PCIPCI with stent implantation | Procedure or surgery | O-APT group, S-APT group |
| Ticagrelor plus aspirinTicagrelor plus aspirin | Drug | O-APT group, S-APT group |
Primary outcome
Major cardiovascular and cerebrovascular adverse events
Time frame: Up to 12 months after PCI
Participants with death from cardiovascular causes, non-fatal myocardial infarction, stent thrombosis,Ischemia driven coronary revascularization and ischemic stroke.Intention to treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee.
Major bleeding events
Time frame: Up to 12 months after PCI
Plato massive hemorrhage events, including fatal hemorrhage, intracranial hemorrhage, pericardial hemorrhage with pericardial tamponade, hypovolemic shock or severe hypotension caused by hemorrhage, requiring pressor or surgery, hemoglobin level dropping 5.0 g or more per deciliter, or at least requiring blood transfusion. Events were adjudicated by an endpoint committee. BARC type 2, 3 or 5 bleeding. Events were adjudicated by an endpoint committee.
The net adverse clinical events
Time frame: Up to 12 months after PCI
included major adverse cardiovascular and cerebrovascular events or major bleeding events.
4 secondary outcomes
Participants with myocardial infarction (MI) event.
Time frame: Up to 36 months after PCI
Participants with death from cardiovascular causes.
Time frame: Up to 36 months after PCI
Participants with death from any cause.
Time frame: Up to 36 months after PCI
PLATO-defined any bleeding event.
Time frame: Up to 36 months after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- 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.
Chen Lianglong, MD, PhD principal investigator
Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention and Ticagrelor plus aspirin in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Fujian Medical University 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 7 inclusion and 13 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 13 May 2020. 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.
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 Chen Lianglong, MD, PhD (+86-13950303022, lianglongchen@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular and cerebrovascular adverse events (time frame: Up to 12 months after PCI). The study lists 3 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 2020.