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Not yet recruiting NCT07468500

Real World Adherence of PCSK9 Targeted Therapy

— Observational Dyslipidemia, Hypercholesterolemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Dyslipidemia, Hypercholesterolemia. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real World Adherence of PCSK9 Targeted Therapy: A Retrospective Analysis of Japan Databases

Overview

Retrospective observational cohort study to compare medication adherence at 12 months between patients in Japan with dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) who newly initiate inclisiran versus those who newly initiate evolocumab.

Primary outcome measures

  • Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent [Time frame: 12 months]
Secondary outcome measures (4)
  • Proportion of patients with good adherence [Time frame: 12 months]
  • Number of patients by demographic category [Time frame: Baseline]
  • Time to discontinuation [Time frame: 12 months]
  • Proportion of patients receiving LLTs [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

The patients are included if they meet all the following criteria:

  • At least one prescription of inclisiran or evolocumab (140 mg Pens) during the identification period.
  • At least one diagnosis of dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) without suspicion flag during the look back period.
  • At least 18 years on the index date.
  • At least one claim record within the 210 days prior to the index date (excluding the index date).

Exclusion criteria

Those with any of the following criteria will be excluded.

  • Both prescription records of inclisiran and evolocumab 140 mg Pens on the index date.
  • At least one claim data for inclisiran or evolocumab 140 mg Pens within the 210 days prior to the index date (excluding the index date).
  • At least one claim data for evolocumab 420 mg Auto mini-dosers during the observation period.
  • Incomplete data for the one year (365 days) follow-up period due to loss to follow-up (the end of the observation period) or death. (only for adherence cohort).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07468500 · CKJX839A1JP08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗