Pulmonary EmbolismPhase 3MAC-PRONCT05946811
Macitentan to Prevent PRVO
A Phase 3 study testing Macitentan 10mg in people with Pulmonary Embolism, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Macitentan 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Jun 2028
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old.
- Acute high-risk or intermediate-risk PE diagnosed by CTPA within 28 days prior to enrollment
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: The Role of MACitentan on the Prevention of Residual Pulmonary vasculaR Occlusion
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:
Read more
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
- Being tested
- Macitentan 10mg
- Keywords
- macitentan, pulmonary embolism, pulmonary hypertension, post-PE syndrome
- Medical subject headings
- Pulmonary Embolism, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macitentan 10mgDrug
Macitentan 10 mg oral once daily for 3 months. vs placebo
| Study group | Role | What they receive |
|---|---|---|
| Macitentan arm | Experimental | Participants allocated to this arm will receive Macitentan 10 mg daily for 3 months Receives: Drug: Macitentan 10mg |
| Placebo | Placebo comparator | Participants allocated to this arm will receive placebo daily for 3 months. Receives: Drug: Macitentan 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of pulmonary artery occlusion (Residual pulmonary vascular occlusion or RPVO)
To quantify RPVO we will use the Qanadli index (QI). The Qanadli index divides each pulmonary artery (right and left) into 10 segments. The presence of a thrombus in a segmental artery is scored with 1 point, a thrombus in the most proximal arterial level is scored with a value equal to the number of segmental arteries arising from that artery. The degree of obstruction score is obtained as follows: 0 when no thrombus, 1 is partially occlusive, and 2 is totally occlusive. The maximum possible index is 40. The percentage of obstruction is calculated using the following formula: % = QI Score /40 x 100. Percent of obstruction will be calculated at baseline and 3-month CT scan. The difference between 3 month-baseline percent of occlusion will be compared between Macitentan and placebo groups.
Measured: 3 months
Secondary outcomes (2)
The difference in levels of biomarkers of endothelial dysfunction and vascular remodeling
We will measure markers of endothelial dysfunction (CD31, CD41, CD62, CD144, CD54), change in diameter of brachial artery in millimeters from the flow mediated vasodilatation test (FMDba), FeNO levels in PPM and biomarkers of NO metabolism (ROS, ADMA, L-Arginine, Citrulline, NO and NOx) at baseline and at 3 months. We will compare the difference between 3-month -baseline values between the Macitentan and the placebo groups.
Measured: 3 months
The difference in scores of functional capacity and severity of pulmonary hypertension
We will obtain questionnaires of quality of life (SF-36 and PEmb), a six-minute walking test, and the pulmonary pressure by echocardiogram, at baseline and 3-month visit. The difference between 3-month and baseline will be compared between the Macitentan and placebo groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Why it stopped: Study was cancelled by funding agency before starting enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Cires-Drouet, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946811
- Sponsor's protocol ID
- HP-00106867
- Acronym
- MAC-PRO
- Status last verified
- Mar 2024
- First submitted
- 26 Jun 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of MACitentan on the Prevention of Residual Pulmonary vasculaR Occlusion
- ClinicalTrials.gov ID
- NCT05946811
- Acronym / sponsor ID
- MAC-PRO / HP-00106867
- Conditions
- Pulmonary Embolism
- Keywords
- macitentan, pulmonary embolism, pulmonary hypertension, post-PE syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled by funding agency before starting enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Macitentan arm | Experimental | Drug: Macitentan 10mgParticipants allocated to this arm will receive Macitentan 10 mg daily for 3 months |
| Placebo | Placebo comparator | Drug: Macitentan 10mgParticipants allocated to this arm will receive placebo daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75 years old.
- Acute high-risk or intermediate-risk PE diagnosed by CTPA within 28 days prior to enrollment
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macitentan 10mgMacitentan 10 mg oral once daily for 3 months. vs placebo | Drug | Macitentan arm, Placebo |
Primary outcome
The percentage of pulmonary artery occlusion (Residual pulmonary vascular occlusion or RPVO)
Time frame: 3 months
To quantify RPVO we will use the Qanadli index (QI). The Qanadli index divides each pulmonary artery (right and left) into 10 segments. The presence of a thrombus in a segmental artery is scored with 1 point, a thrombus in the most proximal arterial level is scored with a value equal to the number of segmental arteries arising from that artery. The degree of obstruction score is obtained as follows: 0 when no thrombus, 1 is partially occlusive, and 2 is totally occlusive. The maximum possible index is 40. The percentage of obstruction is calculated using the following formula: % = QI Score /40 x 100. Percent of obstruction will be calculated at baseline and 3-month CT scan. The difference between 3 month-baseline percent of occlusion will be compared between Macitentan and placebo groups.
2 secondary outcomes
The difference in levels of biomarkers of endothelial dysfunction and vascular remodeling
Time frame: 3 months
The difference in scores of functional capacity and severity of pulmonary hypertension
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Macitentan 10mg in people with Pulmonary Embolism, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of pulmonary artery occlusion (Residual pulmonary vascular occlusion or RPVO) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.