CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 130 enrolled
Drug / intervention
Haemostasis tests +2 morebiological
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/NCT03424460
NCT03424460N/ACompleted

Venous Thromboembolism in Myotonic Dystrophy Type 1

Assistance Publique - Hôpitaux de Paris·interventional·Posted Feb 7, 2018·Updated Sep 12, 2025

In Brief

A clinical study evaluating Haemostasis tests, Monocytes and megacaryocytes culture and RNA extraction, and 1 other intervention for Myotonic Dystrophy 1. Completed, enrolled 130 participants across 1 site.

Detailed Summary

Investigators identified a high risk of deep vein thrombosis and pulmonary embolism in patients presenting myotonic dystrophy type 1 treated in our hospital, 10 times higher than general population matched on age and sex. These venous thromboembolic events were frequently severe and lethal. Investigators suspect that this high risk of venous thromboembolism is due to coagulation abnormalities specific to myotonic dystrophy type 1. The purpose of this study is to determine: 1/ if there is a hypercoagulable state in myotonic dystrophy type 1 by testing patient's coagulation, and 2/ if genes encoding factors involved in coagulation have modified expression resulting in this hypercoagulable state. Understanding the pathophysiology will help preventing venous thromboembolism in these patients. It is the first study to describe this specific issue.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 7, 2018
Enrollment StartJun 11, 2018
Primary CompletionMar 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.4 years ago

Interventions

Haemostasis testsbiological

Venipuncture of 30 milliliters of blood. The following tests will be performed: thromboelastography (TEG®), standard tests of coagulation, genetic thrombophilia, lupus anticoagulant, fibrinolysis markers (Alpha-2-antiplasmin, amidolytic activity, plasmin anti-plasmin complexes, Plasminogen Activator Inhibitor-1 (PAI-1) antigen, plasminogen amydolytic activity), and a global test of fibrinolytic activity.

Monocytes and megacaryocytes culture and RNA extractionbiological

Venipuncture of 60 milliliters of blood. Monocytes and megacaryocytes culture. RNA extraction from monocytes and megacaryocytes.

RNA extractiongenetic

RNA extraction from liver tissue