Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer
NCT ID: NCT05976893
Last Updated: 2023-08-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
620 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-08-01
Study Completion Date
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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ASCVD
Atherosclerotic Cardiovascular Disease
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
patients with very high risk of ASCVD and cancer
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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the PCSK9 inhibitor plus statin therapy
Patients with very high risk of ASCVD and cancer are treated with moderate intensity statin daily and evolocumab (420 mg) every 4 weeks throughout the study period.
Group Type
EXPERIMENTAL
Evolocumab
Intervention Type
DRUG
Evolocuma:420 mg every 4 weeks
Statin
Intervention Type
DRUG
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).
the statin alone therapy
Patients with very high risk of ASCVD and cancer are treated with moderate intensity statin daily throughout the study period.
Group Type
OTHER
Statin
Intervention Type
DRUG
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).
Interventions
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Evolocumab
Evolocuma:420 mg every 4 weeks
Intervention Type
DRUG
Statin
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).
Intervention Type
DRUG
Other Intervention Names
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Repatha
Eligibility Criteria
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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)
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Xinjiang Medical University
OTHER
Sponsor Role
collaborator
Xiang Xie
OTHER
Sponsor Role
lead
Responsible Party
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Xiang Xie
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Xiang Xie, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Xinjiang Medical University
Central Contacts
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References
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Other Identifiers
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PICVDAC
Identifier Type: -
Identifier Source: org_study_id
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