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

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, 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.

Conditions

• Elevated Lipoprotein(a) Level
• Coronary Artery Disease
• Drug-Eluting Stent
• Dual Antiplatelet Therapy

Interventions

PROCEDURE

24 Months DAPT

All subjects will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 12 months after randomization. The DAPT will last for 24 months after PCI.

PROCEDURE

12 Months DAPT

All the subjects will receive aspirin (100 mg/day) + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel for 12 months after randomization. The DAPT will last for 12 months after PCI.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases

  lead OTHER_GOV

Principal Investigators

• Kefei Dou, MD, PhD · Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

• Kongyong Cui, MD, PhD · Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-20

Primary Completion

2028-12-31

Completion

2028-12-31

Countries

• China

Study Locations