Macitentan to Prevent PRVO

NCT ID: NCT05946811

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2028-06-01

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.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Macitentan arm

Participants allocated to this arm will receive Macitentan 10 mg daily for 3 months

Group Type: EXPERIMENTAL

Macitentan 10mg

Intervention Type: DRUG

Macitentan 10 mg oral once daily for 3 months. vs placebo

Placebo

Participants allocated to this arm will receive placebo daily for 3 months.

Group Type: PLACEBO_COMPARATOR

Macitentan 10mg

Intervention Type: DRUG

Macitentan 10 mg oral once daily for 3 months. vs placebo

Interventions

Macitentan 10mg

Macitentan 10 mg oral once daily for 3 months. vs placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-75 years old.
• Acute high-risk or intermediate-risk PE diagnosed by CTPA within 28 days prior to enrollment

Exclusion Criteria

• Contraindication for anticoagulation
• Allergy or contraindications to Macitentan or any other endothelin receptor antagonist.
• Surgical interventions to treat PE including catheter-directed thrombolysis, catheter-based thrombectomy, or surgical pulmonary embolectomy.
• Known inherited or acquired hypercoagulable states
• History of pulmonary embolism prior to index PE
• History of pulmonary hypertension including Group 1 (Primary pulmonary hypertension), Group 2 (secondary to left heart disease), Group 3 (secondary to lung disease), Group 4 (Chronic thromboembolic pulmonary hypertension)
• Severe chronic obstructive pulmonary disease
• Severe uncontrolled asthma
• Pregnancy or fertility treatment
• Breastfeeding
• Life expectancy is less than 6 months
• History of radiation therapy to the chest
• Current or previous use within 90 days of an endothelin-receptor antagonist, prostacyclin analogue, phosphodiesterase type 5 inhibitor, or nitric oxide donor.
• Severe allergic reaction to iodine contrast
• Subjects receiving CYP3A4 and CYP2C9 inhibitors or inducers such as rifampin, ritonavir, fluconazole, amiodarone
• Not able to read or understand the English language

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Rafael Cires-Drouet

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00106867

Identifier Type: -

Identifier Source: org_study_id