NCT03720067

Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension

Propranolol, Carvedilol and Rosuvastatin in the Prevention of Recurrent Variceal Haemorrhage in Patients With Cirrhotic Portal Hypertension

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis
• Portal Hypertension
• Variceal Hemorrhage

Interventions

Type	Name	Description
DRUG	Propranolol	40mg to 320mg / day
DRUG	Carvedilol	6.25mg to 25mg / day
DRUG	Rosuvastatin	20mg / day
DRUG	Placebo	Placebo of rosuvastatin

Timeline

• Start date: 2019-01-25
• Primary completion: 2020-12-20
• Completion: 2022-12-20
• First posted: 2018-10-25
• Last updated: 2019-05-14

Locations

1 site across 1 country: Brazil