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

NCT06014060 | Recruiting DMC

• 1 other identifier: Lipoprotein(a) and prognosis
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Keywords

Lipoprotein(a); Coronary Artery Disease; Drug-Eluting Stent; Percutaneous Coronary Intervention; Dual Antiplatelet Therapy

Outcome Measures

Primary Outcomes (2)

• Major adverse cardiovascular and cerebrovascular event (MACCE)

  The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, non-fatal myocardial infarction or stroke.

  12 months after randomization

• BARC type 3 or 5 bleeding

  Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding

  12 months after randomization

Secondary Outcomes (15)

• Net adverse clinical event (NACE)

  12 months after randomization

• Cardiovascular death or myocardial infarction

  12 months after randomization

• All-cause death or myocardial infarction

  12 months after randomization

• Stent thrombosis

  12 months after randomization

• Any myocardial infarction

  12 months after randomization

Study Arms (2)

24 Months DAPT

EXPERIMENTAL

Dual antiplatelet therapy consisting of aspirin and clopidogrel will be continued for 12 months after randomisation.

Procedure: 24 Months DAPT

12 Months DAPT

ACTIVE COMPARATOR

Aspirin + a placebo that is exactly the same in size, color, smell, taste and appearance as clopidogrel were administered for 12 months after randomisation.

Procedure: 12 Months DAPT

Interventions

24 Months DAPT PROCEDURE

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.

24 Months DAPT

12 Months DAPT PROCEDURE

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.

12 Months DAPT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or nonpregnant female between 18-75 years;
• Subjects with Lp(a) levels \> 30mg/dL before percutaneous coronary intervention (PCI);
• 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
• Subjects (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed;

You may not qualify if:

• Subjects with Lp(a) \< 30mg/dL or Lp(a) level unavailable before PCI;
• 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;
• BARC type 2, 3, or 5 bleeding occurred before PCI
• 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;
• Discontinuation of DAPT for ≥14 days for planned surgical procedures in the next 12 months;
• Systolic blood pressure \< 90mmHg for \> 30 minutes accompanied by hypoperfusion symptoms or systolic blood pressure ≥ 90mmHg is maintained with mechanical/pharmacologic hemodynamic support;
• Persistent symptoms of myocardial ischemia;
• Moderate to severe heart failure (New York Heart Association \[NYHA\] Functional Classification III or IV) or last known left ventricular ejection fraction (LVEF) \< 40%;
• Severe valvular heart disease, myocarditis or cardiomyopathy;
• Severe hepatic insufficiency (ALT or AST \> 3 times upper limit of normal, total bilirubin \> 2.5 times upper limit of normal);
• 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;
• Severe acute or chronic infectious disease;
• History of severe rheumatic immune disease or malignant tumor;
• 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);
• Drug or alcohol abuse, and inability/unwillingness to abstain from drug abuse and excessive alcohol consumption during the study;

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Kefei Dou, MD, PhD

  Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

• Kongyong Cui, MD, PhD

  Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kefei Dou, MD, PhD

CONTACT

+86-10-13801032912; drdoukefei@126.com

Kongyong Cui,, PhD

CONTACT

+86-10-15210519790; cardio_kongyong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study investigators, clinicians, participants, clinical assessors (including the follow-up research personnel, clinical events committee \[CEC\]) were unaware of the study-group assignments. All potential events were adjudicated according to prespecified criteria by an independent clinical events committee whose members were unaware of the trial-group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 28, 2023
• Study Start: June 20, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)