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Macitentan for Cardiac Vasculopathy
Phase 4
Waitlist Available
Led By Rushi Parikh, MD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study week 1 (time of 1 year post-transplant coronary angiogram)
Awards & highlights
Study Summary
This trial is studying whether a drug that lowers levels of a molecule called endothelin-1 can help prevent transplant-related disease in the coronary arteries supplying hearts of transplant patients.
Eligible Conditions
- Cardiac Vasculopathy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study week 1 (time of 1 year post-transplant coronary angiogram)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study week 1 (time of 1 year post-transplant coronary angiogram)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Macitentan: Nitroglycerin (NTG) Luminal Dilation Ratio as Proportion of Vasomotor Tone Attributable to Endothelin-1 (ET-1)
Side effects data
From 2019 Phase 4 trial • 89 Patients • NCT0231067222%
Oedema Peripheral
21%
Headache
14%
Dizziness
11%
Upper Respiratory Tract Infection
11%
Haemoglobin Decreased
11%
Cough
10%
Myalgia
9%
Diarrhoea
9%
Nasal Congestion
8%
Back Pain
8%
Pyrexia
7%
Pain in Extremity
7%
Nasopharyngitis
7%
Nausea
6%
Flushing
3%
Pneumonia
2%
Pulmonary Embolism
2%
Pulmonary Arterial Hypertension
2%
Sepsis
2%
Acute Myocardial Infarction
1%
Cytomegalovirus Infection
1%
Cholangitis Infective
1%
Herpes Zoster
1%
Hypersensitivity
1%
Therapeutic Response Decreased
1%
Escherichia Bacteraemia
1%
Epistaxis
1%
Urinary Tract Infection
1%
Hypoglycaemia
1%
Rheumatoid Arthritis
1%
Pancreatic Carcinoma
1%
Systemic Lupus Erythematosus
1%
Syncope
1%
Acute Kidney Injury
1%
Dysfunctional Uterine Bleeding
1%
Anaemia
1%
Haemolytic Anaemia
1%
Iron Deficiency Anaemia
1%
Angina Pectoris
1%
Atrial Fibrillation
1%
Cardiac Arrest
1%
Coronary Artery Disease
1%
Right Ventricular Failure
1%
Ventricular Hypokinesia
1%
Rectal Haemorrhage
1%
Dysmenorrhoea
1%
Menorrhagia
1%
Pelvic Haemorrhage
1%
Dyspnoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Macitentan 10 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention ArmExperimental Treatment1 Intervention
A consecutive subset of eligible patients based on inclusion/exclusion criteria will receive a 1-week course of Macitentan (10 mg po daily) prior to their routine 1-year coronary angiogram (7th and final dose of Macitentan will occur on the day of the angiogram).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Macitentan
2020
Completed Phase 4
~1920
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,529 Previous Clinical Trials
10,277,783 Total Patients Enrolled
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,971 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,811 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Macitentan a safe and reliable medication for individuals?
"Macitentan has been given approval, so it is rated a 3 for safety."
Answered by AI
Is this research study currently accepting participants?
"Affirmative. Records hosted on clinicaltrials.gov demonstrate that this medical experiment, which was initially introduced on May 19th 2022, is actively recruiting volunteers. Approximately 30 people are needed to be enrolled from a single facility."
Answered by AI
How many participants have been admitted to the experiment?
"Affirmative. As shown by the information on clinicaltrials.gov, this experiment is currently recruiting participants. This trial was initially posted on May 19th 2022 and its details were most recently amended on May 9th 2022. 30 patients are being sought from a single medical facility."
Answered by AI
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