Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer

Launched by XIANG XIE · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called a PCSK9 inhibitor to see how it affects patients who have a very high risk of serious heart problems (known as atherosclerotic cardiovascular disease or ASCVD) and also have cancer. The study aims to find out if this treatment can help reduce the chances of life-threatening events like heart attacks, strokes, or the need for heart surgery.

To be eligible for this trial, participants need to be between the ages of 18 and 80, have documented heart disease or significant risk factors for heart disease, and must have been diagnosed with cancer. They also need to have specific cholesterol levels that are considered high. Participants will receive the PCSK9 inhibitor and will be closely monitored throughout the study. It's important to know that this trial is not yet recruiting participants, so if you think you might be eligible, you can check back later for more information on how to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female ≥ 18 to ≤ 80 years of age
• * Patients with very high risk of ASCVD (with any of the following):
• • 1. Documented ASCVD, either clinical or unequivocal on imaging. Documented ASCVD includes previous acute coronary syndrome (ACS), stable angina, coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft, and other arterial revascularization procedures), stroke and transient ischemic attack (TIA), and peripheral arterial disease. Unequivocally documented ASCVD on imaging includes those findings that are known to be predictive of clinical events, such as significant plaque on coronary angiography or computed tomography (CT) scan (multivessel coronary disease with two major epicardial arteries having \>50% stenosis), or on carotid ultrasound.
• • 2. Diabetes mellitus (DM) with target organ damage, or at least three major risk factors, or early onset of type 1 diabetes mellitus (T1DM) of long duration (\>20 years).
• • Patients have been diagnosed with cancer through histopathology and have a life expectancy of more than 1 year
• • Fasting low-density lipoprotein cholesterol (LDL-C) ≥ 1.8 mmol/L or non-high-density lipoprotein cholesterol (non HDL-C) \> 2.6 mmol/L
• • Participate voluntarily and sign an informed consent
• • Negative serum Pregnancy test (in women with fertility potential)
• Exclusion Criteria:
• • Pregnant and lactating women
• • During the study period and within 3 months of receiving the last dose of the study drug, women with fertility intentions and men unwilling to use effective contraceptive methods
• • New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction \< 30%
• • Uncontrolled hypertension, defined as systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg
• • Plan for coronary revascularization or other cardiac surgery in recent (within 3 months after randomization)
• • Severe renal insufficiency, defined as estimated glomerular filtration rate (eGRF) \< 30ml/min/1.73m2 or Serum creatinine (Scr) \> 221 umol/L
• • Severe liver dysfunction, defined as an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3 times above the upper limit of normal
• • Have used PCSK9 inhibitors within 3 months before enrollment, or have a history of severe allergic reactions to PCSK9 inhibitors
• • Severe infections requiring intravenous antibiotics
• • HIV-positive or history of acquired immunodeficiency syndrome (AIDS)
• • With cognitive impairment or psychiatric illnesses
• • Participating in other trials