Elevated Lipoprotein(a) LevelDAPT-Lp(a)NCT06014060
24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels: A Prospective, Multicenter, Double-Blind, Placebo-Controlled Randomized Trial
A study testing 24 Months DAPT and 12 Months DAPT in people with Elevated Lipoprotein(a) Level and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
1. Main objective Among patients with elevated Lp(a) levels (>30mg/dL) who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding within 12 months after PCI and DES implantation, was it possible to reduce the primary adverse cardiovascular and cerebrovascular events (a composite endpoint consisting… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Elevated Lipoprotein(a) Level, Coronary Artery Disease, Drug-Eluting Stent
- What is being tested?
- 24 Months DAPT and 12 Months DAPT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Dec 2028
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or nonpregnant female between 18-75 years;
- Subjects with Lp(a) levels > 30mg/dL before percutaneous coronary intervention (PCI);
- PCI procedure with drug-eluting stent (DES) implantation and no cardiovascular events or BARC type 2, 3, or 5 bleeding events occurring within 12 months after the procedure
- Subjects (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed;
Who cannot join
- Subjects with Lp(a) < 30mg/dL or Lp(a) level unavailable before PCI;
- Subjects who experience adverse cardiovascular events (death, myocardial infarction, stent thrombosis, stroke, repeat coronary revascularization, or Bleeding Academic Research Consortium [BARC] type 2, 3 or 5 bleeding) within 1-year after PCI;
- BARC type 2, 3, or 5 bleeding occurred before PCI
- Unable to tolerate DAPT therapy or anticoagulant therapy at the same time, long-term use of non-steroidal anti-inflammatory drugs is required Or glucocorticoids;
- Discontinuation of DAPT for ≥14 days for planned surgical procedures in the next 12 months;
- Systolic blood pressure < 90mmHg for > 30 minutes accompanied by hypoperfusion symptoms or systolic blood pressure ≥ 90mmHg is maintained with mechanical/pharmacologic hemodynamic support;
Show all 21Show fewer
- Persistent symptoms of myocardial ischemia;
- Moderate to severe heart failure (New York Heart Association [NYHA] Functional Classification III or IV) or last known left ventricular ejection fraction (LVEF) < 40%;
- Severe valvular heart disease, myocarditis or cardiomyopathy;
- Severe hepatic insufficiency (ALT or AST > 3 times upper limit of normal, total bilirubin > 2.5 times upper limit of normal);
- Severe renal dysfunction, defined as creatinine clearance <30 mL/min or estimated glomerular filtration (eGFR) rate less than 30 ml/min/1.73m2, or requirement for peritoneal dialysis or hemodialysis for renal insufficiency;
- Severe acute or chronic infectious disease;
- History of severe rheumatic immune disease or malignant tumor;
- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies), or receiving other investigational agent(s);
- Drug or alcohol abuse, and inability/unwillingness to abstain from drug abuse and excessive alcohol consumption during the study;
- Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal);
- Known significant active and uncontrolled disease, or any medical, physical condition, as judged by the investigator Or surgical status, may interfere with participation in this study
- Mental/psychological disorder or any other reason that the subject is expected to have difficulty complying with the study requirements or understanding the participants With the objectives and potential risks of the study;
- To the knowledge of the investigator, subjects were unlikely to follow up or were not expected to complete 1 year of follow-up;
- Life expectancy is less than 1 year;
- 22. Refusal to participate in the study
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, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Kefei Dou, MD, PhD, +86-10-13801032912, drdoukefei@126.com
Kongyong Cui, MD, PhD, +86-10-15210519790, cardio_kongyong@163.com
About this study
- Main objective Among patients with elevated Lp(a) levels (>30mg/dL) who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding within 12 months after PCI and DES implantation, was it possible to reduce the primary adverse cardiovascular and cerebrovascular events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, and stroke) by extending the duration of DAPT (24 months) compared to the standard duration (12 months)? (Efficacy test)
- Secondary Objectives Key secondary research objective: Among patients with elevated Lp(a) levels (> 30mg/dL) who underwent PCI and received DES implantation within 12 months after the procedure, and who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding, whether extending the DAPT duration (24 months) compared to the standard DAPT duration (12 months) does not result in an increase in clinical net adverse events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, stroke, and BARC type 3 or 5 bleeding) compared to the standard DAPT duration. (Non-inferiority test) Other secondary research objectives: To evaluate the differences in the incidence of the composite endpoint consisting of BARC type 3 or 5 bleeding (the primary safety endpoint) between extending the DAPT duration (24 months) and the standard DAPT duration (12 months); the differences in the incidence of the composite endpoint consisting of cardiovascular death and myocardial infarction; the differences in the incidence of the composite endpoint consisting of all-cause death and myocardial infarction; the differences in the incidence of stent thrombosis; the differences in the incidence of any myocardial infarction; the differences in the incidence of target vessel myocardial infarction; the differences in the incidence of stroke; the differences in the incidence of ischemic stroke; the differences in the incidence of hemorrhagic stroke; the differences in the incidence of cardiovascular death; the differences in the incidence of all-cause death; the differences in the incidence of repeat revascularization; the differences in the incidence of target vessel revascularization; the differences in the incidence of BARC type 2, 3, or 5 bleeding; the differences in the incidence of any bleeding.
Read the detailed description
Lp(a) levels play an important role in predicting subsequent ischemic events in patients with established coronary artery disease (CAD), especially those who underwent PCI. However, there are still no approved pharmacologic therapies that specifically target high Lp(a) levels.
DAPT consisting of aspirin and a P2Y12 receptor inhibitor represents the cornerstone of pharmacological treatment aimed at preventing thrombotic complications after PCI. Considering that Lp(a) has a prothrombotic effect through its inactive, plasminogen-like protease domain on apo(a), the investigators speculate that prolonged DAPT may have a beneficial effect on reducing future ischemic events in patients with elevated Lp(a) levels after PCI. Some observational studies revealed that DAPT > 1 year was significantly associated with lower risk of cardiovascular events compared with DAPT ≤ 1 year in patients with elevated Lp(a) levels who were event-free at 1 year after PCI with DES. However, the relative efficacy and safety of prolonged DAPT versus standard DAPT in this high-risk population has never been assessed in randomized controlled trials (RCTs).
The DAPT-Lp(a) trial is a multicenter, parallel-group, randomized controlled trial with blinded end-point evaluation. Consecutive patients with Lp(a) levels>30mg/dL who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to 24-month DAPT group or 12-month DAPT group. The investigators hypothesise that, in patients with Lp(a) levels >30mg/dL who were event-free at 1 year after PCI with DES, 24-month DAPT is superior to 12-month DAPT with respect to major adverse cardiovascular and cerebrovascular events (primary end point), while it is non-inferior to 12-month DAPT with respect to net adverse clinical events (key secondary end point).
The investigators estimated that 3,300 patients would be needed to provide the necessary number of confirmed endpoints to test the study hypothesis. Patients will be followed up at 3, 6, 9, 12 months after randomization. All analyses will be performed according to the intention-to-treat (ITT) principle.
- Conditions
- Elevated Lipoprotein(a) Level, Coronary Artery Disease, Drug-Eluting Stent, Dual Antiplatelet Therapy
- Being tested
- 24 Months DAPT, 12 Months DAPT
- Keywords
- Lipoprotein(a), Coronary Artery Disease, Drug-Eluting Stent, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 Months DAPTProcedure or surgery
All subjects will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 12 months after randomization. The DAPT will last for 24 months after PCI.
12 Months DAPTProcedure or surgery
All the subjects will receive aspirin (100 mg/day) + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel for 12 months after randomization. The DAPT will last for 12 months after PCI.
| Study group | Role | What they receive |
|---|---|---|
| 24 Months DAPT | Experimental | Dual antiplatelet therapy consisting of aspirin and clopidogrel will be continued for 12 months after randomisation. Receives: Procedure: 24 Months DAPT |
| 12 Months DAPT | Active comparator | Aspirin + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel were administered for 12 months after randomisation. Receives: Procedure: 12 Months DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular event (MACCE)
The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, non-fatal myocardial infarction or stroke.
Measured: 12 months after randomization
BARC type 3 or 5 bleeding
Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding
Measured: 12 months after randomization
Secondary outcomes (15)
Net adverse clinical event (NACE)
The key secondary endpoint was net adverse clinical event, defined as a composite of all-cause death, non-fatal myocardial infarction, stroke or Bleeding Academic Research Consortium (BARC)] type 3 or 5 bleeding.
Measured: 12 months after randomization
Cardiovascular death or myocardial infarction
Number of patients with a first occurrence of adjudicated composite of cardiovascular death or myocardial infarction.
Measured: 12 months after randomization
All-cause death or myocardial infarction
Number of patients with a first occurrence of adjudicated composite of all-cause death or myocardial infarction.
Measured: 12 months after randomization
Stent thrombosis
Number of patients with the adjudicated stent thrombosis.
Measured: 12 months after randomization
Any myocardial infarction
Number of patients with a first occurrence of adjudicated any myocardial infarction.
Measured: 12 months after randomization
Target vessel myocardial infarction
Number of patients with a first occurrence of adjudicated target vessel myocardial infarction.
Measured: 12 months after randomization
Stroke
Number of patients with a first occurrence of adjudicated stroke.
Measured: 12 months after randomization
Ischemic stroke
Number of patients with a first occurrence of adjudicated ischemic stroke.
Measured: 12 months after randomization
Hemorrhagic stroke
Number of patients with a first occurrence of adjudicated hemorrhagic stroke.
Measured: 12 months after randomization
Cardiovascular death
Number of patients with the occurrence of adjudicated cardiovascular death.
Measured: 12 months after randomization
All-cause death
Number of patients with a first occurrence of adjudicated confirmed all-cause death
Measured: 12 months after randomization
Repeat revascularization
Number of patients with a first occurrence of adjudicated repeat revascularization.
Measured: 12 months after randomization
Target vessel revascularization
Number of patients with a first occurrence of adjudicated target vessel revascularization.
Measured: 12 months after randomization
BARC type 2, 3 or 5 bleeding
Number of patients with a first occurrence of adjudicated BARC type 2, 3 or 5 bleeding.
Measured: 12 months after randomization
Any bleeding
Number of patients with a first occurrence of adjudicated any bleeding.
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 posted28 Aug 2023
- Study start20 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Lipoprotein(a) LevelStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kefei Dou, MD, China National Center for Cardiovascular Diseases
- Investigators
- Kefei Dou, MD, PhD, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeKongyong Cui, MD, PhD, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014060
- Sponsor's protocol ID
- Lipoprotein(a) and prognosis
- Acronym
- DAPT-Lp(a)
- Status last verified
- Jul 2025
- First submitted
- 23 Aug 2023
- Last updated
- 18 Jul 2025
- 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 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels: A Prospective, Multicenter, Double-Blind, Placebo-Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT06014060
- Acronym / sponsor ID
- DAPT-Lp(a) / Lipoprotein(a) and prognosis
- Conditions
- Elevated Lipoprotein(a) Level, Coronary Artery Disease, Drug-Eluting Stent, Dual Antiplatelet Therapy
- Keywords
- Lipoprotein(a), Coronary Artery Disease, Drug-Eluting Stent, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Aug 2023 (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.
- Main objective Among patients with elevated Lp(a) levels (>30mg/dL) who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding within 12 months after PCI and DES implantation, was it possible to reduce the primary adverse cardiovascular and cerebrovascular events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, and stroke) by extending the duration of DAPT (24 months) compared to the standard duration (12 months)? (Efficacy test)
- Secondary Objectives Key secondary research objective: Among patients with elevated Lp(a) levels (> 30mg/dL) who underwent PCI and received DES implantation within 12 months after the procedure, and who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding, whether extending the DAPT duration (24 months) compared to the standard DAPT duration (12 months) does not result in an increase in clinical net adverse events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, stroke, and BARC type 3 or 5 bleeding) compared to the standard DAPT duration. (Non-inferiority test) Other secondary research objectives: To evaluate the differences in the incidence of the composite endpoint consisting of BARC type 3 or 5 bleeding (the primary safety endpoint) between extending the DAPT duration (24 months) and the standard DAPT duration (12 months); the differences in the incidence of the composite endpoint consisting of cardiovascular death and myocardial infarction; the differences in the incidence of the composite endpoint consisting of all-cause death and myocardial infarction; the differences in the incidence of stent thrombosis; the differences in the incidence of any myocardial infarction; the differences in the incidence of target vessel myocardial infarction; the differences in the incidence of stroke; the differences in the incidence of ischemic stroke; the differences in the incidence of hemorrhagic stroke; the differences in the incidence of cardiovascular death; the differences in the incidence of all-cause death; the differences in the incidence of repeat revascularization; the differences in the incidence of target vessel revascularization; the differences in the incidence of BARC type 2, 3, or 5 bleeding; the differences in the incidence of any bleeding.
Detailed description
Lp(a) levels play an important role in predicting subsequent ischemic events in patients with established coronary artery disease (CAD), especially those who underwent PCI. However, there are still no approved pharmacologic therapies that specifically target high Lp(a) levels.
DAPT consisting of aspirin and a P2Y12 receptor inhibitor represents the cornerstone of pharmacological treatment aimed at preventing thrombotic complications after PCI. Considering that Lp(a) has a prothrombotic effect through its inactive, plasminogen-like protease domain on apo(a), the investigators speculate that prolonged DAPT may have a beneficial effect on reducing future ischemic events in patients with elevated Lp(a) levels after PCI. Some observational studies revealed that DAPT > 1 year was significantly associated with lower risk of cardiovascular events compared with DAPT ≤ 1 year in patients with elevated Lp(a) levels who were event-free at 1 year after PCI with DES. However, the relative efficacy and safety of prolonged DAPT versus standard DAPT in this high-risk population has never been assessed in randomized controlled trials (RCTs).
The DAPT-Lp(a) trial is a multicenter, parallel-group, randomized controlled trial with blinded end-point evaluation. Consecutive patients with Lp(a) levels>30mg/dL who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to 24-month DAPT group or 12-month DAPT group. The investigators hypothesise that, in patients with Lp(a) levels >30mg/dL who were event-free at 1 year after PCI with DES, 24-month DAPT is superior to 12-month DAPT with respect to major adverse cardiovascular and cerebrovascular events (primary end point), while it is non-inferior to 12-month DAPT with respect to net adverse clinical events (key secondary end point).
The investigators estimated that 3,300 patients would be needed to provide the necessary number of confirmed endpoints to test the study hypothesis. Patients will be followed up at 3, 6, 9, 12 months after randomization. All analyses will be performed according to the intention-to-treat (ITT) principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 Months DAPT | Experimental | Procedure: 24 Months DAPTDual antiplatelet therapy consisting of aspirin and clopidogrel will be continued for 12 months after randomisation. |
| 12 Months DAPT | Active comparator | Procedure: 12 Months DAPTAspirin + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel were administered for 12 months after randomisation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or nonpregnant female between 18-75 years;
- Subjects with Lp(a) levels > 30mg/dL before percutaneous coronary intervention (PCI);
- PCI procedure with drug-eluting stent (DES) implantation and no cardiovascular events or BARC type 2, 3, or 5 bleeding events occurring within 12 months after the procedure
- Subjects (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed;
Key exclusion criteria (21 listed)
- Subjects with Lp(a) < 30mg/dL or Lp(a) level unavailable before PCI;
- Subjects who experience adverse cardiovascular events (death, myocardial infarction, stent thrombosis, stroke, repeat coronary revascularization, or Bleeding Academic Research Consortium [BARC] type 2, 3 or 5 bleeding) within 1-year after PCI;
- BARC type 2, 3, or 5 bleeding occurred before PCI
- Unable to tolerate DAPT therapy or anticoagulant therapy at the same time, long-term use of non-steroidal anti-inflammatory drugs is required Or glucocorticoids;
- Discontinuation of DAPT for ≥14 days for planned surgical procedures in the next 12 months;
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 |
|---|---|---|
| 24 Months DAPTAll subjects will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 12 months after randomization. The DAPT will last for 24 months after PCI. | Procedure or surgery | 24 Months DAPT |
| 12 Months DAPTAll the subjects will receive aspirin (100 mg/day) + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel for 12 months after randomization. The DAPT will last for 12 months after PCI. | Procedure or surgery | 12 Months DAPT |
Primary outcome
Major adverse cardiovascular and cerebrovascular event (MACCE)
Time frame: 12 months after randomization
The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, non-fatal myocardial infarction or stroke.
BARC type 3 or 5 bleeding
Time frame: 12 months after randomization
Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding
15 secondary outcomes
Net adverse clinical event (NACE)
Time frame: 12 months after randomization
Cardiovascular death or myocardial infarction
Time frame: 12 months after randomization
All-cause death or myocardial infarction
Time frame: 12 months after randomization
Stent thrombosis
Time frame: 12 months after randomization
Any myocardial infarction
Time frame: 12 months after randomization
Target vessel myocardial infarction
Time frame: 12 months after randomization
Stroke
Time frame: 12 months after randomization
Ischemic stroke
Time frame: 12 months after randomization
Hemorrhagic stroke
Time frame: 12 months after randomization
Cardiovascular death
Time frame: 12 months after randomization
All-cause death
Time frame: 12 months after randomization
Repeat revascularization
Time frame: 12 months after randomization
Target vessel revascularization
Time frame: 12 months after randomization
BARC type 2, 3 or 5 bleeding
Time frame: 12 months after randomization
Any bleeding
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 Jul 2025.
- 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.
Kefei Dou, MD, PhD principal investigator
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Kongyong Cui, MD, PhD principal investigator
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24 Months DAPT and 12 Months DAPT in people with Elevated Lipoprotein(a) Level and Coronary Artery Disease, run by China National Center for Cardiovascular Diseases 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 4 inclusion and 21 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 Jul 2025. 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?
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 Kefei Dou, MD, PhD (+86-10-13801032912, drdoukefei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular event (MACCE) (time frame: 12 months after randomization). 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 18 Jul 2025.