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Study was cancelled by funding agency before starting enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macitentan arm | Experimental | Participants allocated to this arm will receive Macitentan 10 mg daily for 3 months |
|
| Placebo | Placebo Comparator | Participants allocated to this arm will receive placebo daily for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macitentan 10mg | Drug | Macitentan 10 mg oral once daily for 3 months. vs placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| C533860 | macitentan |
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| 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. | 6 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |