Status:
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
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Elevated Lipoprotein(a) Level
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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, w...
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...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
- 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
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
3300 Patients enrolled
Trial Details
Trial ID
NCT06014060
Start Date
June 20 2025
End Date
December 31 2028
Last Update
July 18 2025
Active Locations (1)
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1
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100037