24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels (DAPT-Lp(a))
Elevated Lipoprotein(a) Level, Coronary Artery Disease, Drug-Eluting Stent
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
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
Experimental
Active Comparator
24 Months DAPT
12 Months DAPT
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.