Deep Venous Thrombosis Clinical Trial
Official title:
International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity
The three purposes of this study are the following:
- To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux
(SSR126517) with that of idraparinux (SR34006), taking into account new events of deep
venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
- To compare the activities of idrabiotaparinux and idraparinux directly in blood during
and after a 6-month treatment;
- To check the ability of avidin (SSR29261) to reverse the blood thinning activity of
idrabiotaparinux at the end of a 6-month treatment period.
The study consists in a 6-month treatment period followed by an observational period of 3 to
6 months with a month 9 visit and a phone/contact visit at month 12.
All participants who complete the 6-month treatment period are re-randomized to either the
idrabiotaparinux/idraparinux bioequipotency sub-study or the avidin neutralizing effect
sub-study.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
| Completed |
NCT02889562 -
Apixaban Versus Warfarin for the Management of Post-operative Atrial Fibrillation
|
Phase 2/Phase 3 | |
| Completed |
NCT01333618 -
Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter
|
N/A | |
| Completed |
NCT00812370 -
The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids
|
Phase 1 | |
| Completed |
NCT02552420 -
The Clinical Application of Infrared Thermal Imaging Detecting Venous Thromboembolism
|
Phase 2/Phase 3 | |
| Completed |
NCT00178789 -
Sonography Outcomes Assessment Program for Lower Extremity Deep Venous Thrombosis
|
Phase 1/Phase 2 | |
| Completed |
NCT03251963 -
Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients
|
Phase 2 | |
| Completed |
NCT03286985 -
The Prevalence and Incidence of DVT in General ICU
|
||
| Completed |
NCT04414332 -
Registry of Angiovac Procedures In Detail Outcomes Database-RAPID Registry
|
||
| Completed |
NCT02211326 -
Genotype-guided Warfarin Individualized Treatment
|
N/A | |
| Completed |
NCT03296280 -
Evaluation of Implementation of a National Point-of-Care Ultrasound Training Program
|
||
| Recruiting |
NCT03937583 -
Screening for Cancer in Patients With Unprovoked VTE
|
Phase 4 | |
| Completed |
NCT00628576 -
Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower Extremities
|
Phase 3 | |
| Completed |
NCT04979026 -
Clinical Investigation of a Novel Approach for the Prevention of Deep Venous Thrombosis After Total Knee Replacement
|
N/A | |
| Active, not recruiting |
NCT02318472 -
Early Mobilization After Achilles Tendon Rupture
|
N/A | |
| Completed |
NCT01221805 -
STA®-Liatest®D-Di-Exclusion of Venous Thromboembolism
|
Phase 4 | |
| Recruiting |
NCT03740633 -
Functional Training for the Prevention of Deep Venous Thrombosis
|
Phase 3 | |
| Completed |
NCT03707665 -
Deep Venous Thrombosis Screening in the ICU by Nurses
|
||
| Recruiting |
NCT05171049 -
A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE
|
Phase 3 | |
| Terminated |
NCT01573169 -
PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
|
Phase 3 |