Viewing Study NCT05946811



Ignite Creation Date: 2024-05-06 @ 7:15 PM
Last Modification Date: 2024-10-26 @ 3:03 PM
Study NCT ID: NCT05946811
Status: WITHDRAWN
Last Update Posted: 2024-03-08
First Post: 2023-06-26

Brief Title: Macitentan to Prevent PRVO
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: The Role of MACitentan on the Prevention of Residual Pulmonary vasculaR Occlusion
Status: WITHDRAWN
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Study was cancelled by funding agency before starting enrollment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MAC-PRO
Brief Summary: About half of patients who suffer of a pulmonary embolism blood clots in the lungs do not clear completely the clots overtime increasing the risk of having a new blood clot in the lungs and elevated blood pressure in the pulmonary artery therefore developing fatigue shortness of breath and heart failure

The objective of this clinical trial is to compare 3 months of daily Macitentan a medicine to increase the diameter of the pulmonary artery in addition to blood thinners vs blood thinners alone in patients with acute blood clots in the pulmonary artery

Question 1 Whether the use of Macitentan in addition to blood thinners enhances the process of cleaning the blood clot in the pulmonary artery compared to blood thinners alone

Question 2 Whether the use of Macitentan in addition to blood thinners is associated to improve the fatigue and shortness of breath in patients after a pulmonary embolism compared to blood thinners alone

Participants will be asked to take a capsule for 3 months in addition to blood thinners The capsule could contain either Macitentan medicine or a placebo not medicine In 3 months participants will have a new image of the pulmonary artery to document the cleaning of the clots Also blood and urine samples will be collected as well as a questionnaire will be filled out In 6 months patients will have repeated images of the heart as well as repeated questionnaires
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None