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24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels (DAPT-Lp(a))

Primary Purpose

Elevated Lipoprotein(a) Level, Coronary Artery Disease, Drug-Eluting Stent

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
24 Months DAPT
12 Months DAPT
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elevated Lipoprotein(a) Level focused on measuring Lipoprotein(a), Coronary Artery Disease, Drug-Eluting Stent, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or nonpregnant female between 18-75 years; Subjects with Lp(a) levels > 30mg/dL before percutaneous coronary intervention (PCI); Subjects who are event-free at 1 year after PCI with drug-eluting stent (DES); Subjects (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed; Subjects are willing to comply with all protocol-required follow-up evaluation. Exclusion Criteria: 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; Subjects who have other diseases requiring dual antiplatelet therapy (DAPT) such as peripheral vascular disease; Subjects who cannot tolerate DAPT therapy or receive anticoagulation therapy at the time of randomization; Planned surgery necessitating discontinuation of antiplatelet therapy (>14 days) within the 12 months after randomization; Systolic blood pressure < 90mmHg for > 30 minutes accompanied by hypoperfusion symptoms or systolic blood pressure ≥ 90mmHg is maintained with mechanical/pharmacologic hemodynamic support; Unstable or severe pulmonary edema/decompensated congestive heart failure; 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; Recurrent symptoms of ischemia; 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; History or clinical evidence of active liver disease or hepatic dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN), or total bilirubin > 2 × ULN; Unexplained elevated creatine kinase (CK) concentration >5 × ULN or elevation due to known muscle disease; 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; Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal); Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge; Any uncontrolled or serious disease, or any medical or surgical condition (such as known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction, or a chronic disease or infection [eg, HIV]), that may either interfere with participation in the clinical study and is not currently stable and appropriately managed in the judgment of the investigator, and/or put the subject at significant risk (according to investigator's judgment) if he/she participates in the clinical study; Mental/psychological impairment/neurocognitive disorder, or any other reason to expect patient difficulty in complying with the requirements of the study or understanding the goal and potential risks of participating in the study; Concurrent medical condition with a life expectancy of < 1 year; Subject unable to give informed consent;

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

24 Months DAPT

12 Months DAPT

Arm Description

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

Dual antiplatelet therapy will be discontinued and patients will receive aspirin monotherapy for 12 months after randomisation.

Outcomes

Primary Outcome Measures

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, myocardial infarction or stroke.

Secondary Outcome Measures

Net adverse clinical event (NACE)
The key secondary endpoint was net adverse clinical event, defined as a composite of all-cause death, myocardial infarction, stroke or Bleeding Academic Research Consortium (BARC)] type 3 or 5 bleeding.
Cardiovascular death or myocardial infarction
Number of patients with a first occurrence of adjudicated composite of cardiovascular death or myocardial infarction.
All-cause death or myocardial infarction
Number of patients with a first occurrence of adjudicated composite of all-cause death or myocardial infarction.
All-cause death
Number of patients with the occurrence of adjudicated all-cause death.
Cardiovascular death
Number of patients with the occurrence of adjudicated cardiovascular death.
Any myocardial infarction
Number of patients with a first occurrence of adjudicated any myocardial infarction.
Target vessel myocardial infarction
Number of patients with a first occurrence of adjudicated target vessel myocardial infarction.
Stroke
Number of patients with a first occurrence of adjudicated stroke.
Ischemic stroke
Number of patients with a first occurrence of adjudicated ischemic stroke.
Hemorrhagic stroke
Number of patients with a first occurrence of adjudicated hemorrhagic stroke.
Definite/probable stent thrombosis
Number of patients with a first occurrence of adjudicated definite/probable stent thrombosis.
Repeat revascularization
Number of patients with a first occurrence of adjudicated repeat revascularization.
Target vessel revascularization
Number of patients with a first occurrence of adjudicated target vessel revascularization.
Any bleeding
Number of patients with a first occurrence of adjudicated any bleeding.
BARC type 2, 3 or 5 bleeding
Number of patients with a first occurrence of adjudicated BARC type 2, 3 or 5 bleeding.
BARC type 3 or 5 bleeding
Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding.

Full Information

First Posted
August 23, 2023
Last Updated
August 26, 2023
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT06014060
Brief Title
24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels
Acronym
DAPT-Lp(a)
Official Title
24-Month Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is (1) to determine whether 24-month dual antiplatelet therapy (DAPT) is superior to 12-month DAPT after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) with respect to major adverse cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, or stroke) in patients with elevated lipoprotein(a)[Lp(a)] levels (>30mg/dL); (2) to determine whether 24-month DAPT is non-inferior to 12-month DAPT after PCI with DES with respect to net adverse clinical events (all-cause death, myocardial infarction, stroke or Bleeding Academic Research Consortium [BARC] type 3 or 5 bleeding) in patients with elevated Lp(a) levels (>30mg/dL).
Detailed Description
Lp(a) levels play an important role in predicting subsequent ischemic events in patients with established coronary artery disease (CAD), especially those who underwent PCI. However, there are still no approved pharmacologic therapies that specifically target high Lp(a) levels. DAPT consisting of aspirin and a P2Y12 receptor inhibitor represents the cornerstone of pharmacological treatment aimed at preventing thrombotic complications after PCI. Considering that Lp(a) has a prothrombotic effect through its inactive, plasminogen-like protease domain on apo(a), the investigators speculate that prolonged DAPT may have a beneficial effect on reducing future ischemic events in patients with elevated Lp(a) levels after PCI. Some observational studies revealed that DAPT > 1 year was significantly associated with lower risk of cardiovascular events compared with DAPT ≤ 1 year in patients with elevated Lp(a) levels who were event-free at 1 year after PCI with DES. However, the relative efficacy and safety of prolonged DAPT versus standard DAPT in this high-risk population has never been assessed in randomized controlled trials (RCTs). The DAPT-Lp(a) trial is a multicenter, parallel-group, randomized controlled trial with blinded end-point evaluation. Consecutive patients with Lp(a) levels>30mg/dL who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 fashion to 24-month DAPT group or 12-month DAPT group. The investigators hypothesise that, in patients with Lp(a) levels >30mg/dL who were event-free at 1 year after PCI with DES, 24-month DAPT is superior to 12-month DAPT with respect to major adverse cardiovascular and cerebrovascular events (primary end point), while it is non-inferior to 12-month DAPT with respect to net adverse clinical events (key secondary end point). The investigators estimated that 3,300 patients would be needed to provide the necessary number of confirmed endpoints to test the study hypothesis. Patients will be followed up at 3, 6, 9, 12 months after randomization. All analyses will be performed according to the intention-to-treat (ITT) principle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Participants and study investigators were aware of the study-group assignments, but outcome adjudicators were not. All potential events were adjudicated according to prespecified criteria by an independent clinical events committee whose members were unaware of the trial-group assignments.
Allocation
Randomized
Enrollment
3300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
24 Months DAPT
Arm Type
Experimental
Arm Description
Dual antiplatelet therapy consisting of aspirin and clopidogrel will be continued for 12 months after randomisation.
Arm Title
12 Months DAPT
Arm Type
Active Comparator
Arm Description
Dual antiplatelet therapy will be discontinued and patients will receive aspirin monotherapy for 12 months after randomisation.
Intervention Type
Procedure
Intervention Name(s)
24 Months DAPT
Intervention Description
All subjects will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 12 months after randomization.
Intervention Type
Procedure
Intervention Name(s)
12 Months DAPT
Intervention Description
All subjects will receive aspirin (100 mg/day) monotherapy without co-administration of clopidogrel for 12 months after randomization.
Primary Outcome Measure Information:
Title
Major adverse cardiovascular and cerebrovascular event (MACCE)
Description
The primary endpoint was major adverse cardiovascular and cerebrovascular event (MACCE), defined as a composite of all-cause death, myocardial infarction or stroke.
Time Frame
12 months after randomization
Secondary Outcome Measure Information:
Title
Net adverse clinical event (NACE)
Description
The key secondary endpoint was net adverse clinical event, defined as a composite of all-cause death, myocardial infarction, stroke or Bleeding Academic Research Consortium (BARC)] type 3 or 5 bleeding.
Time Frame
12 months after randomization
Title
Cardiovascular death or myocardial infarction
Description
Number of patients with a first occurrence of adjudicated composite of cardiovascular death or myocardial infarction.
Time Frame
12 months after randomization
Title
All-cause death or myocardial infarction
Description
Number of patients with a first occurrence of adjudicated composite of all-cause death or myocardial infarction.
Time Frame
12 months after randomization
Title
All-cause death
Description
Number of patients with the occurrence of adjudicated all-cause death.
Time Frame
12 months after randomization
Title
Cardiovascular death
Description
Number of patients with the occurrence of adjudicated cardiovascular death.
Time Frame
12 months after randomization
Title
Any myocardial infarction
Description
Number of patients with a first occurrence of adjudicated any myocardial infarction.
Time Frame
12 months after randomization
Title
Target vessel myocardial infarction
Description
Number of patients with a first occurrence of adjudicated target vessel myocardial infarction.
Time Frame
12 months after randomization
Title
Stroke
Description
Number of patients with a first occurrence of adjudicated stroke.
Time Frame
12 months after randomization
Title
Ischemic stroke
Description
Number of patients with a first occurrence of adjudicated ischemic stroke.
Time Frame
12 months after randomization
Title
Hemorrhagic stroke
Description
Number of patients with a first occurrence of adjudicated hemorrhagic stroke.
Time Frame
12 months after randomization
Title
Definite/probable stent thrombosis
Description
Number of patients with a first occurrence of adjudicated definite/probable stent thrombosis.
Time Frame
12 months after randomization
Title
Repeat revascularization
Description
Number of patients with a first occurrence of adjudicated repeat revascularization.
Time Frame
12 months after randomization
Title
Target vessel revascularization
Description
Number of patients with a first occurrence of adjudicated target vessel revascularization.
Time Frame
12 months after randomization
Title
Any bleeding
Description
Number of patients with a first occurrence of adjudicated any bleeding.
Time Frame
12 months after randomization
Title
BARC type 2, 3 or 5 bleeding
Description
Number of patients with a first occurrence of adjudicated BARC type 2, 3 or 5 bleeding.
Time Frame
12 months after randomization
Title
BARC type 3 or 5 bleeding
Description
Number of patients with a first occurrence of adjudicated BARC type 3 or 5 bleeding.
Time Frame
12 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or nonpregnant female between 18-75 years; Subjects with Lp(a) levels > 30mg/dL before percutaneous coronary intervention (PCI); Subjects who are event-free at 1 year after PCI with drug-eluting stent (DES); Subjects (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed; Subjects are willing to comply with all protocol-required follow-up evaluation. Exclusion Criteria: 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; Subjects who have other diseases requiring dual antiplatelet therapy (DAPT) such as peripheral vascular disease; Subjects who cannot tolerate DAPT therapy or receive anticoagulation therapy at the time of randomization; Planned surgery necessitating discontinuation of antiplatelet therapy (>14 days) within the 12 months after randomization; Systolic blood pressure < 90mmHg for > 30 minutes accompanied by hypoperfusion symptoms or systolic blood pressure ≥ 90mmHg is maintained with mechanical/pharmacologic hemodynamic support; Unstable or severe pulmonary edema/decompensated congestive heart failure; 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; Recurrent symptoms of ischemia; 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; History or clinical evidence of active liver disease or hepatic dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN), or total bilirubin > 2 × ULN; Unexplained elevated creatine kinase (CK) concentration >5 × ULN or elevation due to known muscle disease; 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; Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal); Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge; Any uncontrolled or serious disease, or any medical or surgical condition (such as known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction, or a chronic disease or infection [eg, HIV]), that may either interfere with participation in the clinical study and is not currently stable and appropriately managed in the judgment of the investigator, and/or put the subject at significant risk (according to investigator's judgment) if he/she participates in the clinical study; Mental/psychological impairment/neurocognitive disorder, or any other reason to expect patient difficulty in complying with the requirements of the study or understanding the goal and potential risks of participating in the study; Concurrent medical condition with a life expectancy of < 1 year; Subject unable to give informed consent;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kefei Dou, MD, PhD
Phone
+86-10-13801032912
Email
drdoukefei@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kongyong Cui,, PhD
Phone
+86-10-15210519790
Email
cardio_kongyong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kefei Dou, MD, PhD
Organizational Affiliation
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kongyong Cui, MD, PhD
Organizational Affiliation
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kefei Dou, MD, PhD
Phone
+86-10-13801032912
Email
drdoukefei@126.com
First Name & Middle Initial & Last Name & Degree
Kongyong Cui, MD, PhD
Phone
+86-10-15210519790
Email
cardio_kongyong@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels

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