drugset / Trial / NCT03720067
Propranolol, Carvedilol and Rosuvastatin in the Prevention of Variceal Bleeding in Cirrhotic Portal Hypertension
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2019-01-25
- Primary completion
- 2020-12-20
- Completion
- 2022-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carvedilol | Other / unclassified | 6.25 mg | Oral |
| Comparator | Carvedilol | Other / unclassified | 25 mg | Oral |
| Comparator | Propranolol | Small molecule | 40 mg | Oral |
| Comparator | Propranolol | Small molecule | 320 mg | Oral |
| Comparator | Rosuvastatin | Small molecule | 20 mg | Oral |