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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 belowSelect...
I am between 18 and 75 years old.
MAC-PRO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 • NCT0255490314%
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%
Weight Increased
7%
Hypotension
7%
Acute Kidney Injury
7%
Pleural Effusion
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%
Neuropathy Peripheral
4%
Neck Mass
4%
Orthostatic Hypotension
4%
Dermatitis
4%
Fluid Overload
4%
Urinary Tract Infection
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%
Hypoxia
4%
Chest Discomfort
4%
Impaired Healing
4%
Post Procedural Haemorrhage
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
687 Previous Clinical Trials
374,646 Total Patients Enrolled
3 Trials studying Pulmonary Embolism
20,331 Patients Enrolled for Pulmonary Embolism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery or a catheter procedure for a pulmonary embolism.You have had a severe allergic reaction to iodine contrast before.I am not taking medications like rifampin, ritonavir, fluconazole, or amiodarone.I have had radiation therapy to my chest before.Doctors think you have less than 6 months to live.I was diagnosed with a serious or moderate pulmonary embolism less than 28 days ago.You are pregnant or undergoing fertility treatment.I have severe COPD.My asthma is severe and not under control.I have a condition that makes my blood clot more than normal.I have had a lung clot before my current one.I cannot take blood thinners due to health reasons.I am not allergic to Macitentan or similar medications.I have a history of high blood pressure in the lungs.I am between 18 and 75 years old.I have used specific heart or lung medication in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Macitentan arm
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards exist with Macitentan use?
"We rate the safety of Macitentan as a 3, since it has been through Phase 3 trials which have provided reliable evidence for its effectiveness and multiple assessments vouching for its security."
Answered by AI
Could you provide information on the availability of this experimental treatment?
"Clinicaltrials.gov has indicated that this particular trial, which was initially posted on May 1st 2024 and updated lastly on July 7th 2023, is not currently looking for participants. Nevertheless, there are 80 other medical trials actively recruiting patients right now."
Answered by AI
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