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

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · Aug 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different lengths of dual antiplatelet therapy (DAPT) in patients who have high levels of a substance called lipoprotein(a) [Lp(a)] and have undergone a procedure to place a drug-eluting stent in their heart. Specifically, the trial will compare 24 months of DAPT to 12 months of DAPT to see which duration is better at preventing serious heart-related issues, like heart attacks or strokes. The goal is to find out if a longer treatment is more effective without increasing the risk of bleeding complications.

To be eligible for this trial, participants must be between 18 and 75 years old, have Lp(a) levels higher than 30 mg/dL before their heart procedure, and be free of major heart events for at least a year after getting their stent. If you join the study, you will receive either the 12-month or 24-month treatment and will need to follow up regularly to monitor your health. It’s important to note that certain health conditions, like severe heart failure or recent serious cardiovascular events, may prevent someone from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or nonpregnant female between 18-75 years;
• • 2. Subjects with Lp(a) levels \> 30mg/dL before percutaneous coronary intervention (PCI);
• • 3. 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
• • 4. Subjects (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed;
• Exclusion Criteria:
• • 1. Subjects with Lp(a) \< 30mg/dL or Lp(a) level unavailable before PCI;
• • 2. 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;
• • 3. BARC type 2, 3, or 5 bleeding occurred before PCI
• • 4. 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;
• • 5. Discontinuation of DAPT for ≥14 days for planned surgical procedures in the next 12 months;
• • 6. Systolic blood pressure \< 90mmHg for \> 30 minutes accompanied by hypoperfusion symptoms or systolic blood pressure ≥ 90mmHg is maintained with mechanical/pharmacologic hemodynamic support;
• • 7. Persistent symptoms of myocardial ischemia;
• • 8. Moderate to severe heart failure (New York Heart Association \[NYHA\] Functional Classification III or IV) or last known left ventricular ejection fraction (LVEF) \< 40%;
• • 9. Severe valvular heart disease, myocarditis or cardiomyopathy;
• • 10. Severe hepatic insufficiency (ALT or AST \> 3 times upper limit of normal, total bilirubin \> 2.5 times upper limit of normal);
• • 11. 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;
• • 12. Severe acute or chronic infectious disease;
• • 13. History of severe rheumatic immune disease or malignant tumor;
• • 14. 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);
• • 15. Drug or alcohol abuse, and inability/unwillingness to abstain from drug abuse and excessive alcohol consumption during the study;
• • 16. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal);
• • 17. 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
• • 18. 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;
• • 19. To the knowledge of the investigator, subjects were unlikely to follow up or were not expected to complete 1 year of follow-up;
• • 20. Life expectancy is less than 1 year;
• • 22. Refusal to participate in the study