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

NCT05976893 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2023-08-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Evolocumab

Evolocuma:420 mg every 4 weeks

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).

Sponsors & Collaborators

  • Xinjiang Medical University

    collaborator OTHER

  • Xiang Xie

    lead OTHER

Principal Investigators

  • Xiang Xie, PhD · First Affiliated Hospital of Xinjiang Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05976893 on ClinicalTrials.gov