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Macitentan for Pulmonary Embolism (MAC-PRO Trial)

Phase 3
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-75 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

MAC-PRO Trial Summary

This trial will test if a medicine (Macitentan) can help clear blood clots in the lungs, & reduce fatigue & shortness of breath. Participants take a capsule & have images & tests over 3 & 6 months.

Who is the study for?
This trial is for adults aged 18-75 who've recently had a high-risk or intermediate-risk pulmonary embolism (PE) and haven't cleared the clots. It's not for those with a history of PE, severe lung conditions, certain heart diseases, allergies to Macitentan or similar drugs, pregnant women, or those on specific medications like CYP3A4 inhibitors.Check my eligibility
What is being tested?
The study tests if adding Macitentan to standard blood thinners helps clear blood clots in the lungs better than blood thinners alone. Participants will take either Macitentan or a placebo for three months and undergo imaging and questionnaires to track clot clearance and symptoms like fatigue and breathlessness.See study design
What are the potential side effects?
Macitentan may cause side effects such as headache, cold-like symptoms, anemia (low red blood cell count), bronchitis, urinary tract infections (UTI), liver function abnormalities, low sperm counts in men, fluid retention leading to swelling in parts of the body.

MAC-PRO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.

MAC-PRO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The percentage of pulmonary artery occlusion (Residual pulmonary vascular occlusion or RPVO)
Secondary outcome measures
The difference in levels of biomarkers of endothelial dysfunction and vascular remodeling
The difference in scores of functional capacity and severity of pulmonary hypertension

Side effects data

From 2020 Phase 2 trial • 57 Patients • NCT02554903
14%
Oedema Peripheral
14%
Dizziness
14%
N-Terminal Prohormone Brain Natriuretic Peptide Increased
11%
Fatigue
11%
Dyspnoea
11%
Anticoagulation Drug Level below Therapeutic
11%
Cystatin C Increased
7%
Pruritus
7%
Pleural Effusion
7%
Weight Increased
7%
Hypotension
7%
Acute Kidney Injury
7%
Nausea
7%
Vomiting
7%
Blood Creatinine Increased
7%
Upper Respiratory Tract Infection
7%
Medical Device Site Infection
7%
Right Ventricular Failure
7%
Septic Shock
7%
Cough
7%
Epistaxis
7%
Diarrhoea
7%
Blood Urea Increased
7%
Blood Uric Acid Increased
7%
Hyperkalaemia
7%
Hyponatraemia
7%
Abdominal Distension
7%
Orthopnoea
4%
Hypoxia
4%
Fluid Overload
4%
Orthostatic Hypotension
4%
Neck Mass
4%
Urinary Tract Infection
4%
Neuropathy Peripheral
4%
Post Procedural Haemorrhage
4%
Dermatitis
4%
Rash
4%
Ileus
4%
Groin Abscess
4%
Influenza
4%
Haematocrit Decreased
4%
Haemoglobin Decreased
4%
Haemoglobin Abnormal
4%
Sleep Apnoea Syndrome
4%
Breast Tenderness
4%
Liver Function Test Increased
4%
Systolic Dysfunction
4%
Benign Prostatic Hyperplasia
4%
Bacterial Infection
4%
Hypoaesthesia
4%
Lethargy
4%
Depression
4%
Muscle Spasms
4%
Presyncope
4%
Dysuria
4%
Respiratory Tract Infection
4%
International Normalised Ratio Increased
4%
Dyspnoea Exertional
4%
Ventricular Tachycardia
4%
Gastrointestinal Haemorrhage
4%
Gastrooesophageal Reflux Disease
4%
Insomnia
4%
Chest Discomfort
4%
Impaired Healing
4%
Asthenia
4%
Peripheral Swelling
4%
Pyrexia
4%
Electrocardiogram St Segment Elevation
4%
Blood Loss Anaemia
4%
Dyspnoea Paroxysmal Nocturnal
4%
Skin Lesion
4%
Atrial Flutter
4%
Cardiac Failure
4%
Cardiac Failure Acute
4%
Enterococcal Bacteraemia
4%
Troponin Increased
4%
Leukocytosis
4%
Cardiogenic Shock
4%
Cardiorenal Syndrome
4%
Palpitations
4%
Abdominal Pain
4%
Protein Total Decreased
4%
Carpal Tunnel Syndrome
4%
Dysphonia
4%
Blood Alkaline Phosphatase Increased
4%
Blood Sodium Decreased
4%
Constipation
4%
Headache
4%
Pulmonary Hypertension
4%
Blood Bilirubin Increased
4%
Left Ventricular End-Diastolic Pressure Increased
4%
Hypovolaemia
4%
Cerebral Haemorrhage
4%
Anaemia
4%
Dry Mouth
4%
Blood Potassium Decreased
4%
Blood Triglycerides Increased
4%
Smear Cervix Abnormal
4%
Hyperuricaemia
4%
Hypervolaemia
4%
Malnutrition
4%
Dysphagia
4%
Bacteraemia
4%
Hypokalaemia
4%
Respiratory Failure
4%
Fractured Sacrum
4%
Ejection Fraction Decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Macitentan 10 Milligrams (mg)
Placebo

MAC-PRO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Macitentan armExperimental Treatment1 Intervention
Participants allocated to this arm will receive Macitentan 10 mg daily for 3 months
Group II: PlaceboPlacebo Group1 Intervention
Participants allocated to this arm will receive placebo daily for 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Macitentan 10mg
2016
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
692 Previous Clinical Trials
376,864 Total Patients Enrolled
3 Trials studying Pulmonary Embolism
20,331 Patients Enrolled for Pulmonary Embolism

Media Library

Macitentan arm Clinical Trial Eligibility Overview. Trial Name: NCT05946811 — Phase 3
Pulmonary Embolism Research Study Groups: Macitentan arm, Placebo
Pulmonary Embolism Clinical Trial 2023: Macitentan arm Highlights & Side Effects. Trial Name: NCT05946811 — Phase 3
Macitentan arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05946811 — Phase 3
~0 spots leftby Jan 2028
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