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

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ClinicalTrials.gov Identifier: NCT05976893
Recruitment Status : Not yet recruiting
First Posted : August 4, 2023
Last Update Posted : August 4, 2023
Sponsor:
Collaborator:
Xinjiang Medical University
Information provided by (Responsible Party):
Xiang Xie, Xinjiang Medical University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
ASCVD Atherosclerotic Cardiovascular Disease Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Cancer Drug: Evolocumab Drug: Statin Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patients with very high risk of ASCVD and cancer
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Evolocumab
Evolocuma:420 mg every 4 weeks
Other Name: Repatha

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).
the statin alone therapy
Patients with very high risk of ASCVD and cancer are treated with moderate intensity statin daily throughout the study period.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Major cardiovascular adverse events [ Time Frame: From date of randomization until the date of first documented endpoint or date of completion of follow-up, whichever came first, assessed up to 48 weeks ]
    Major cardiovascular adverse events include cardiovascular death, recurrent unstable angina, myocardial infarction, stroke, and coronary revascularization


Secondary Outcome Measures :
  1. All cause death [ Time Frame: From date of randomization until the date of first documented endpoint or date of completion of follow-up, whichever came first, assessed up to 48 weeks ]
    All cause death

  2. Composite end points [ Time Frame: From date of randomization until the date of first documented endpoint or date of completion of follow-up, whichever came first, assessed up to 48 weeks ]
    Composite end points include cardiogenic shock, cardiac arrest, malignant arrhythmia, heart failure, Non-coronary revascularization

  3. The compliance rate of lipid control [ Time Frame: From date of randomization until the date of first documented endpoint or date of completion of follow-up, whichever came first, assessed up to 48 weeks ]
    Main indicator: LDL-C decreased to below 1.4 mmol/L and decreased by more than 50% from baseline; secondary indicator: non HDL-C<2.2 mmol/L;

  4. The changes of carotid plaque [ Time Frame: From date of randomization until the date of first documented endpoint or date of completion of follow-up, whichever came first, assessed up to 48 weeks ]
    By carotid ultrasound


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05976893


Contacts
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Contact: Xiang Xie, PhD +869914366892 xiangxie999@sina.com

Sponsors and Collaborators
Xiang Xie
Xinjiang Medical University
Investigators
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Principal Investigator: Xiang Xie, PhD First Affiliated Hospital of Xinjiang Medical University
More Information
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Publications of Results:

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Responsible Party: Xiang Xie, Principal Investigator, Xinjiang Medical University
ClinicalTrials.gov Identifier: NCT05976893    
Other Study ID Numbers: PICVDAC
First Posted: August 4, 2023    Key Record Dates
Last Update Posted: August 4, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Xiang Xie, Xinjiang Medical University:
ASCVD
cancer
PCSK9
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Evolocumab
PCSK9 Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Lipid Regulating Agents