Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Port… (NCT03720067) | Clinical Trial Compass
UnknownPhase 2/3
Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension
Brazil80 participantsStarted 2019-01-25
Plain-language summary
Patients with hepatic cirrhosis and previous variceal bleeding will be randomly assigned to use propranolol or carvedilol. After 8 weeks, rosuvastatin or placebo will be blindly added to nonresponders (HVPG measurement \> 12mmHg) for another 8 weeks and hemodynamic response will be assessed again.
Surrogate serum markers of portal hypertension will be evaluated and correlated to HVPG values and to its variations.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hepatic cirrhosis of any etiology
* Previous variceal bleeding
* Endoscopic variceal eradication at least 2 weeks before
Exclusion Criteria:
* Beta blocker or statin contraindications
* Model for End-Stage Liver Disease (MELD) score \> 25
* Child-Pugh score \> 13
* HVPG ≤ 12 mmHg
* Creatinine clearance \< 50 mL/min
* Refractory ascites
* Hepatic encephalopathy stages 3 or 4
* Alcohol use in the last 6 months
* Hepatitis C treatment in the last 6 months
* Changing or initiating a new hepatitis B treatment in the last 6 months
* Malignant neoplasms from any origin except basal cell carcinoma
* HIV infection
* Pregnancy
* Anticoagulation
* Recent or complete portal vein thrombosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute hemodynamic response
Timeframe: Two hours after a load dose of carvedilol or propranolol
2
Full hemodynamic response to beta blockers
Timeframe: Eight weeks of carvedilol or propranolol
3
Full hemodynamic response to beta blockers plus rosuvastatin or placebo
Timeframe: Eight weeks of beta blockers plus rosuvastatin or placebo