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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with elevated Lipoprotein(a) levels above 30 mg/dL who have undergone percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation but have not experienced cardiovascular events or significant bleeding within 12 months after the procedure. The trial aims to compare whether extending dual antiplatelet therapy (DAPT) from the standard 12 months to 24 months can reduce major adverse cardiovascular and cerebrovascular events such as death, heart attack, and stroke. This randomized, double-blind trial also evaluates if longer DAPT is as safe as the standard duration regarding bleeding and net adverse clinical events. Participants are randomly assigned to one of two groups: one group receives aspirin combined with clopidogrel for 24 months after PCI, while the other group receives aspirin plus a placebo identical to clopidogrel for 12 months. The therapy is delivered as oral medications daily. The study includes a follow-up period with assessments at 3, 6, 9, and 12 months after randomization to monitor outcomes. The trial is conducted across multiple centers with blinded evaluation of results. During the study, participants will undergo regular monitoring to assess cardiovascular events and bleeding incidents, including all-cause death, myocardial infarction, stroke, stent thrombosis, and various bleeding types classified by the Bleeding Academic Research Consortium. Data will be collected through clinical visits and evaluations at predefined intervals up to 12 months after randomization. The research team will analyze these measures to determine the efficacy and safety of extended DAPT in this high-risk population. The total study duration includes treatment and follow-up phases to ensure comprehensive outcome assessment.
CONDITIONS
Brief 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 between 18 and 75 years old
- Lipoprotein(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 after PCI
- Able and willing to provide written informed consent and comply with study procedures
You will not qualify if you...
- Lipoprotein(a) levels less than 30 mg/dL or unavailable before PCI
- Experienced adverse cardiovascular events or BARC type 2, 3, or 5 bleeding within 12 months after PCI
- BARC type 2, 3, or 5 bleeding before PCI
- Unable to tolerate dual antiplatelet or anticoagulant therapy
- Planned discontinuation of DAPT for 14 days or more due to surgery within 12 months
- Low systolic blood pressure with hypoperfusion or requiring mechanical/pharmacologic 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 or kidney dysfunction
- Severe acute or chronic infection
- History of severe rheumatic immune disease or cancer
- Participation in other investigational drug or device studies within 30 days
- Drug or alcohol abuse
- Major organ transplant recipient
- Significant uncontrolled diseases or conditions interfering with participation
- Mental or psychological disorders affecting compliance
- 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 to 24 months
Participants receive dual antiplatelet therapy consisting of aspirin and either clopidogrel or placebo for 12 to 24 months following drug-eluting stent implantation.
Visits at 3, 6, 9, and 12 months after randomization
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
K
Kongyong Cui,, PhD
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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