Acute Coronary SyndromePhase 4LD-ASPIRINNCT04240834
Ticagrelor With Low-dose Versus Regular Aspirin in Patients With Acute Coronary Syndrome (ACS) at High-Risk for Ischemia After Percutaneous Coronary Intervention
A Phase 4 study testing Aspirin and Ticagrelor in people with Acute Coronary Syndrome and Interventional Cardiology, run by Fu Wai Hospital, Beijing, China at 1 site in China.
Trial summary
The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Interventional Cardiology
- What is being tested?
- Aspirin and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent
- Able and willing to provide informed consent and participate in 12 months follow-up period
- Able to receive DAPT treatment
- Enrollment into the study will require meeting at least one angiographic or clinical inclusion and none of the exclusion criteria.
- Clinical inclusion criteria:
- Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative <55 years old or in first-degree female relative <65 years old)
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- Repeated myocardial infarction
- Positive serum cardiac troponin I/T
- Combined with at least one organ/system with atherosclerotic disease (e.g. intracranial or peripheral arteries)
- Type 2 diabetes mellitus under medication
- Chronic kidney disease (eGFR<60 mL/min/1.73 m2 or CrCl<60ml/min)
- Angiographic Inclusion Criteria:
- LM lesion requiring stents
- Proximal LAD lesion(s) requiring stents
- Bypass grafts lesion(s) requiring stents
- Overall stent length ≥60 mm
- History of in-stent thrombosis
- Bifurcation lesions requiring at least 2 stents
- Over two vessels lesions requiring stents
- Calcified target lesion(s) requiring atherectomy
- The intraoperative occurrence of no-reflow or slow-flow
- Compressed branch vessels with a diameter of at least 2.0 mm failing to reach flow restoration (at least TIMI 3)
Who cannot join
- Need for chronic oral anticoagulation
- With cardiomyopathy（HCM/DCM/RCM）
- With severe ventricular arrhythmia requiring ICD implantation
- With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease)
- With severe infectious disease（active hepatitis B, active hepatitis C, AIDS）
- With hematological disorders（thrombocytopenia, severe anemia, leukaemia）
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- With severe liver disease or kidney failure
- With malignant tumor
- With cognitive impairment
- Unable or unwilling to provide informed consent or undergo follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality
Haiyan Qian, MD, PhD, +8613811386143, ahqhy712@163.com
About this study
Official title: Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Randomized Controlled Study
The present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.
Read the detailed description
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.
- Conditions
- Acute Coronary Syndrome, Interventional Cardiology
- Being tested
- Aspirin, Ticagrelor
- Keywords
- ACS, PCI, DAPI, Aspirin, Ticagrelor
- 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.
AspirinDrug
Also called Acetylsalicylic Acid
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
TicagrelorDrug
Also called Brilinta/Brilique
Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
| Study group | Role | What they receive |
|---|---|---|
| LD group | Experimental | Low-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months Receives: Drug: Aspirin; Drug: Ticagrelor |
| Control group | Active comparator | Regular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months Receives: Drug: Aspirin; Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebral events (MACCEs)
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
Measured: 12 months after randomization
Secondary outcomes (4)
Bleeding episode (Key secondary endpoint)
Number of participants with major bleeding(Bleeding Academic Research Consortium (BARC) types ≥3) and/or minor bleeding(Bleeding Academic Research Consortium (BARC) types 0-2)
Measured: 12 months after randomization
Platelet function
Platelet inhibition, blood level and urine level of thromboxaneB2(TXB2)
Measured: 12 months after randomization
Medication adherence
Measured: 12 months after randomization
Bleeding-related withdrawal
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Feb 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Wai Hospital, Beijing, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Haiyan, Fu Wai Hospital, Beijing, China
- Investigators
- Haiyan Qian, MD, PhD, Principal investigator, Fuwai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240834
- Sponsor's protocol ID
- 2019XK320061
- Acronym
- LD-ASPIRIN
- Status last verified
- Jun 2024
- First submitted
- 22 Jan 2020
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ticagrelor With Low-dose Aspirin Versus Regular Aspirin in Patients With Acute Coronary Syndrome at High-risk for Ischemia After Percutaneous Coronary Intervention: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04240834
- Acronym / sponsor ID
- LD-ASPIRIN / 2019XK320061
- Conditions
- Acute Coronary Syndrome, Interventional Cardiology
- Keywords
- ACS, PCI, DAPI, Aspirin, Ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,220 participants (estimated)
- Lead sponsor
- Fu Wai Hospital, Beijing, ChinaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 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 present study is aimed to compare the safety and efficacy of Ticagrelor with low-dose Aspirin versus standard dual anti-platelet therapy (DAPT) in patients with acute coronary syndrome (ACS) at high risk for ischemic events after percutaneous coronary intervention (PCI) and stent implantation.
Detailed description
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. There will be 1220 ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent who will be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to either Ticagrelor plus low-dose Aspirin (50mg daily, LD group) or Ticagrelor plus regular dose Aspirin (75mg daily, control group) for 12 months. The primary endpoint of the current study is to determine the impact of low-dose Aspirin plus Ticagrelor versus standard DAPT for 12 months on major adverse cardiac and cerebral events (MACCEs), and the secondary endpoint is to determine whether the protocol of low dose Aspirin plus Ticagrelor reduces bleeding events, sufficiently inhibits platelet function, and increases the medication adherence among the included patients. In summary, the present study is to provide new evidence and strategy about the anti-platelet protocol for ACS patients at high risk for ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LD group | Experimental | Drug: Aspirin, Drug: TicagrelorLow-dose Aspirin(50mg qd) + Ticagrelor( 90mg bid) for 12 months |
| Control group | Active comparator | Drug: Aspirin, Drug: TicagrelorRegular Aspirin(75mg qd) + Ticagrelor(90mg bid) for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- ACS patients at high risk for ischemic events after successful PCI with implantation of at least one drug eluting stent
- Able and willing to provide informed consent and participate in 12 months follow-up period
- Able to receive DAPT treatment
- Enrollment into the study will require meeting at least one angiographic or clinical inclusion and none of the exclusion criteria.
- Family history of premature coronary heart disease (Coronary heart disease in first-degree male relative <55 years old or in first-degree female relative <65 years old)
Key exclusion criteria (10 listed)
- Need for chronic oral anticoagulation
- With cardiomyopathy（HCM/DCM/RCM）
- With severe ventricular arrhythmia requiring ICD implantation
- With chronic respiratory disease (COPD, asthma, chronic bronchitis, pulmonary heart disease)
- With severe infectious disease（active hepatitis B, active hepatitis C, AIDS）
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic AcidComparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT) | Drug | Control group, LD group |
| TicagrelorAlso: Brilinta/BriliqueComparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT) | Drug | Control group, LD group |
Primary outcome
Major adverse cardiac and cerebral events (MACCEs)
Time frame: 12 months after randomization
Number of participants with a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularization
4 secondary outcomes
Bleeding episode (Key secondary endpoint)
Time frame: 12 months after randomization
Platelet function
Time frame: 12 months after randomization
Medication adherence
Time frame: 12 months after randomization
Bleeding-related withdrawal
Time frame: 12 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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.
Haiyan Qian, MD, PhD principal investigator
Fuwai Hospital, Beijing, China
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 Aspirin and Ticagrelor in people with Acute Coronary Syndrome and Interventional Cardiology, run by Fu Wai Hospital, Beijing, China 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 22 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Qian, MD, PhD (+8613811386143, ahqhy712@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerebral events (MACCEs) (time frame: 12 months after randomization). 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 18 Jun 2024.