24-month versus 12-month dual antiplatelet therapy after drug-eluting stent in people with high Lipoprotein(a)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DAPT-Lp(a) trial is a multicenter, randomized, double-blind, placebo-controlled trial enrolling patients with Lp(a) >30 mg/dL who underwent PCI with a drug-eluting stent and remained free of cardiovascular events or significant bleeding during the first year after the procedure. Eligible participants are randomized 1:1 to continue dual antiplatelet therapy for 24 months versus stop P2Y12 therapy after 12 months with matching placebo and are followed for major cardiovascular and cerebrovascular events. The primary outcome is a composite of all-cause death, non-fatal myocardial infarction, and stroke, and key secondary outcomes include clinical net adverse events combining ischemic and major bleeding events. Blinded end-point evaluation is used to reduce bias in outcome assessment.

Why it matters

Who can join: the full rules

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

Where it's running

• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Kefei Dou, MD, PhD — Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
• Study coordinator: Kefei Dou, MD, PhD
• Email: drdoukefei@126.com
• Phone: +86-10-13801032912

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.