PMMHRI-Pitavastatin Registry

NCT ID: NCT06858982

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2028-12-31

Brief Summary

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The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI). Established in January 2024, the registry enrolls all patients from the Department of Cardiology and Adult Congenital Heart Diseases, the Department of Endocrinology, as well as outpatient cardiology and endocrinology clinics who are prescribed pitavastatin.

Detailed Description

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The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI), the second-largest supra-regional hospital in Poland. The registry was initiated in January 2024 to systematically collect real-world data on patients prescribed pitavastatin, aiming to assess its effectiveness, safety, and impact on lipid and cardiovascular risk management.

The registry has included all patients from the Departments of Cardiology and Endocrinology, as well as outpatient cardiology and endocrinology clinics, who have been prescribed pitavastatin. The inclusion of a broad patient population allows for a comprehensive evaluation of treatment patterns and outcomes in routine clinical practice.

Patient data are extracted from electronic medical records and include:

Demographic parameters (age, sex, BMI, etc.) Relevant comorbidities (e.g., hypertension, diabetes, chronic kidney disease) Concomitant medications, including: Lipid-lowering therapy status (monotherapy vs. combination therapy), Anticoagulation status Lifestyle factors, such as smoking status Post hoc calculated cardiovascular risk scores, to stratify patients based on their predicted risk of major adverse cardiovascular events (MACE) Laboratory parameters, including lipid profiles, inflammatory markers, and metabolic indicators.

Conditions

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Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patient takling pitavastatin based on the 2021 Polish Lipid Guidelines

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Polish Mother Memorial Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Polish Mother's Memorial Hospital Research Institute

Lodz, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Maciej Banach, MD,PhD, FNLA, FAHA,FESC, FASA

Role: CONTACT

+48 42 2711599

Facility Contacts

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Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA

Role: primary

+48 42 2711599

Other Identifiers

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PMMHRI-Pitavastatin Registry

Identifier Type: -

Identifier Source: org_study_id

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