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A prospective, observational, multicenter, cohort trial to evaluate the efficacy and safety of PCSK9 inhibitors in patients receiving immune checkpoint inhibitors for malignant tumors combined with coronary atherosclerotic heart disease

A prospective, observational, multicenter, cohort trial to evaluate the efficacy and safety of PCSK9 inhibitors in patients receiving immune checkpoint inhibitors for malignant tumors combined with coronary atherosclerotic heart disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091996
Enrollment
Unknown
Registered
2024-11-07
Start date
2024-11-10
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary atherosclerotic heart disease

Interventions

Non-exposed group (Without receiving PCSK9 inhibitor therapy):none
Exposed group (Receiving PCSK9 inhibitor therapy):none

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Age= 18 years old. 2) ECOG PS 0 or 1; 3) patients with malignant tumors, treated with ICIs; 4) Have been diagnosed with coronary atherosclerotic heart disease, and the overall risk assessment of ASCVD is high risk or above; 5) Able to comply with the protocol for the duration of the study. 6) Provide written informed consent prior to entry into the study, and the patient has understood that the study can be withdrawn at any time without any loss.

Exclusion criteria

Exclusion criteria: 1) Patients with severe dysfunction of important organs such as heart, liver, kidney, and lung. 2) Allergy to iodine or contrast media. 3) Severe water and electrolyte disorders. 4) Presence of coagulation dysfunction. 5) Those who have gastrointestinal bleeding within two weeks before enrollment, or who are judged by the investigator to have a high risk of bleeding. 6) There is an underlying medical condition that, in the opinion of the investigator, is not conducive to the study.

Design outcomes

Primary

MeasureTime frame
Major adverse cardiovascular events;

Secondary

MeasureTime frame
duration of response;Progression-free survival;Overall survival;Drug safety;

Countries

China

Contacts

Public ContactCheng Leilei

Zhongshan Hospital, Fudan University

cheng.leilei@zs-hospital.sh.cn+86 139 1686 6296

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026