Actively Recruiting
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
Led by China National Center for Cardiovascular Diseases · Updated on 2025-07-18
3300
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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) 2. 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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or nonpregnant female aged 18 to 75 years
- Lp(a) levels greater than 30 mg/dL before PCI
- Underwent PCI with drug-eluting stent implantation
- No cardiovascular events or BARC type 2, 3, or 5 bleeding within 12 months post-PCI
- Understands trial requirements and provides written informed consent
You will not qualify if you...
- Lp(a) levels less than 30 mg/dL or unavailable before PCI
- Experienced adverse cardiovascular events or BARC type 2, 3, or 5 bleeding within 1 year after PCI
- BARC type 2, 3, or 5 bleeding before PCI
- Unable to tolerate DAPT or anticoagulant therapy, or requires long-term NSAIDs or glucocorticoids
- Planned discontinuation of DAPT for 14 days or more due to surgery within next 12 months
- Systolic blood pressure below 90 mmHg for over 30 minutes with hypoperfusion or requiring support
- Persistent myocardial ischemia symptoms
- Moderate to severe heart failure (NYHA III or IV) or left ventricular ejection fraction below 40%
- Severe valvular heart disease, myocarditis, or cardiomyopathy
- Severe liver dysfunction (ALT or AST over 3 times normal, total bilirubin over 2.5 times normal)
- Severe kidney dysfunction (creatinine clearance or eGFR less than 30 mL/min/1.73m2) or dialysis
- Severe acute or chronic infection
- History of severe rheumatic immune disease or cancer
- Participation in another investigational drug or device study currently or within 30 days
- Drug or alcohol abuse or unwillingness to abstain during study
- Recipient of major organ transplant
- Significant uncontrolled disease or condition affecting participation
- Mental or psychological disorder affecting study compliance or understanding
- Unlikely to complete 1 year of follow-up
- Life expectancy less than 1 year
- Refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
K
Kefei Dou, MD, PhD
CONTACT
K
Kongyong Cui,, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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