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

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

NCT ID: NCT05976893

Condition: ASCVD
Atherosclerotic Cardiovascular Disease
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
Cancer

Conditions: Official terms:
Cardiovascular Diseases
Atherosclerosis
Evolocumab

Conditions: Keywords:
ASCVD
cancer
PCSK9

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: patients with very high risk of ASCVD and cancer

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Drug
Intervention name: Evolocumab
Description: Evolocuma:420 mg every 4 weeks
Arm group label: the PCSK9 inhibitor plus statin therapy

Other name: Repatha

Intervention type: Drug
Intervention name: Statin
Description: The moderate intensity statins used during the study are one of atorvastatin 10-20mg qd, resuvastatin 5-10mg qd, and xuezhikang 0.6g bid (statin intolerance).
Arm group label: the PCSK9 inhibitor plus statin therapy
Arm group label: the statin alone therapy

Summary: This study is a prospective, randomized, open-label, and single center trial. To evaluate the effect of treatment with PCSK9 inhibitor on the risk for cardiovascular death, recurrent unstable angina, myocardial infarction, stroke, or coronary revascularization in patients with very high risk of atherosclerotic cardiovascular disease (ASCVD) and cancer.

Detailed description: Subjects will be randomly assigned in a 1:1 ratio to receive subcutaneous injections of PCSK9 inhibitor (evolocumab:420 mg every 4 weeks) plus moderate intensity statin therapy or the statin alone therapy. After randomization, patients will come to the hospital every 4 weeks to collect relevant laboratory results and clinical outcomes, and be detected by echocardiography and carotid ultrasound every 12 weeks until the end of follow-up at week 48 or the occurrence of an endpoint event. The entire study is expected to be conducted for 3 years, with a recruitment period of 2 years.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: August 1, 2023

Completion date: December 31, 2025

Lead sponsor:
Agency: Xiang Xie
Agency class: Other

Collaborator:
Agency: Xinjiang Medical University
Agency class: Other

Source: Xinjiang Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05976893