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

Sponsor
Xiang Xie
Study ID
NCT05976893
Phase
PHASE4
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Evolocuma:420 mg every 4 weeks
  • Statin — 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).

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Jul 2023
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
620 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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 ]

Central Contacts

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