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Compares treatment options for Elevated Lipoprotein(a) Level
Official title 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
ClinicalTrials.gov ID: NCT06014060
What this study is testing
- What it's testing
- 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)?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or nonpregnant female between 18-75 years;
- people 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...
- people (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed;
You likely can't join if
- people with Lp(a) \< 30mg/dL or Lp(a) level unavailable before PCI;
- people who experience adverse cardiovascular events (death, myocardial infarction, stent thrombosis, stroke, repeat coronary revascularization, or...
- 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...
- Discontinuation of DAPT for ≥14 days for planned surgical procedures in the next 12 months;
- Systolic blood pressure \ 30 minutes accompanied by hypoperfusion symptoms or systolic blood pressure ≥ 90mmHg is maintained with...
See the full eligibility criteria
- Male or nonpregnant female between 18-75 years;
- people 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
- people (or legal guardian) understand the trial requirements and the treatment procedures and provides written informed;
- people with Lp(a) \< 30mg/dL or Lp(a) level unavailable before PCI;
- people 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)...
- 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 \ 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...
- 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...
- 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);
- Known significant active and uncontrolled disease, or any medical, physical condition, as judged by the investigator Or surgical status, may interfere with participation in this study
- Mental/psychological disorder or any other reason that the subject is expected to have difficulty complying with the study requirements or understanding the participants With the objectives and potential risks of the...
- To the knowledge of the investigator, people were unlikely to follow up or were not expected to complete 1 year of follow-up;
- Life expectancy is less than 1 year; 22\. Refusal to participate in the study
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.