NCT06014060: DAPT-Lp(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

Recruiting now NA Last updated 18 July 2025

What this trial tests

NA trial testing 24 Months DAPT in Elevated Lipoprotein(a) Level in 3,300 participants. Currently enrolling.

Timeline

20 June 2025

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	China National Center for Cardiovascular Diseases
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	3,300
Start date	20 June 2025
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

• 24 Months DAPT
• 12 Months DAPT — full drug profile →

Conditions studied

• Elevated Lipoprotein(a) Level — all drugs for Elevated Lipoprotein(a) Level →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Drug-Eluting Stent — all drugs for Drug-Eluting Stent →
• Dual Antiplatelet Therapy — all drugs for Dual Antiplatelet Therapy →

Sponsor

China National Center for Cardiovascular Diseases — full company profile →

Who can join

Adults 18 to 75, any sex, with Elevated Lipoprotein(a) Level or Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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, was it possible to reduce the primary adverse cardiovascular and cerebrovascular events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, and stroke) by extending the duration of DAPT (24 months) compared to the standard duration (12 months)? (Efficacy test)
2. Secondary Objectives Key secondary research objective: Among patients with elevated Lp(a) levels (\> 30mg/dL) who underwent PCI and received DES implantation within 12 months after the procedure, and who did not experience cardiovascular events or BARC type 2, 3, or 5 bleeding, whether extending the DAPT duration (24 months) compared to the standard DAPT duration (12 months) does not result in an increase in clinical net adverse events (a composite endpoint consisting of all-cause death, non-fatal myocardial infarction, stroke, and BARC type 3 or 5 bleeding) compared to the standard DAPT duration. (Non-inferiority test) Other secondary research objectives: To evaluate the differences in the incidence of the composite endpoint consisting of BARC type 3 or 5 bleeding (the primary safety endpoint) between extending the DAPT duration (24 months) and the standard DAPT duration (12 months); the differences in the incidence of the composite endpoint consisting of cardiovascular death and myocardial infarction; the differences in the incidence of the composite endpoint consisting of all-cause death and myocardial infarction; the differences in the incidence of stent thrombosis; the differences in the incidence of any myocardial infarction; the differences in the incidence of target vessel myocardial infarction; the differences in the incidence of stroke; the differences in the incidence of ischemic stroke; the differences in the incidence of hemorrhagic stroke; the differences in the incidence of cardiovascular death; the differences in the incidence of all-cause death; the differences in the incidence of repeat revascularization; the differences in the incidence of target vessel revascularization; the differences in the incidence of BARC type 2, 3, or 5 bleeding; the differences in the incidence of any bleeding.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.