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

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

This trial will test whether continuing dual antiplatelet therapy for 24 months instead of 12 months lowers the risk of death, heart attack, or stroke in people with high Lipoprotein(a) who had a drug-eluting stent and were event-free at one year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China National Center for Cardiovascular Diseases (Government)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06014060 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with Lp(a) >30 mg/dL who had PCI with a drug-eluting stent and experienced no cardiovascular events or BARC type 2, 3, or 5 bleeding during the first year after the procedure are ideal candidates.

Not a fit: Patients with Lp(a) <30 mg/dL or unknown Lp(a), those who had cardiovascular events or significant bleeding within the first year after PCI, or those who cannot tolerate dual antiplatelet therapy or require long-term anticoagulation are unlikely to benefit.

Why it matters

Potential benefit: If successful, longer dual antiplatelet therapy could reduce the risk of major cardiovascular events in patients with elevated Lp(a) after DES implantation.

How similar studies have performed: Observational studies have suggested prolonged DAPT may lower event rates in patients with high Lp(a), but randomized controlled trials addressing this question have not previously been done.

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

Where this trial is running

Beijing, Beijing Municipality

• 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

Conditions Elevated Lipoprotein Level; Coronary Artery Disease; Drug-Eluting Stent; Dual Antiplatelet Therapy; Lipoprotein; Percutaneous Coronary Intervention