CI

At a glance

ClinicalIndex Comparison Record
Phase 4Active· 15 target
Drug / intervention
Metformin Extended Release Oral Tabletdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05317806
NCT05317806Phase 4ActiveOn TrackUpdated 19mo ago
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Use of Metformin in Prevention and Treatment of Cardiac Fibrosis in PAI-1 Deficient Population

Indiana Hemophilia &Thrombosis Center, Inc.·interventional·Posted Apr 8, 2022·Updated Nov 6, 2024

In Brief

A Phase 4 clinical trial evaluating Metformin Extended Release Oral Tablet for Plasminogen Activator Inhibitor-1 Deficiency and Cardiac Fibrosis. Active but no longer recruiting, targeting 15 participants across 1 site.

Detailed Summary

This study will evaluate the efficacy and safety of metformin, in patients 18-65 years of age with homozygous plasminogen activator inhibitor-1 (PAI-1) deficiency, with or without cardiac fibrosis, for a period of 60 months. The starting dose of metformin will be 500 mg up to a maximum dose of 2000 mg for a period of 5 years with the aim to assess the safety and efficacy of metformin on prevention/stabilization or regression of cardiac fibrosis in a Treated population vs. a Comparison population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasminogen Activator Inhibitor-1 Deficiency, Cardiac Fibrosis
CountriesUnited States
Collaborators--

Timeline

Phase 4Active
20232024202520262027
First PostedApr 8, 2022
Enrollment StartOct 10, 2022
Primary CompletionOct 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 4.2 years agoPrimary completion in 1.2 years

Interventions

Metformin Extended Release Oral Tabletdrug

daily metformin treatment vs. no treatment with metformin