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

NCT03720067 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-05-14

No results posted yet for this study

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

DRUG

Propranolol

40mg to 320mg / day

DRUG

Carvedilol

6.25mg to 25mg / day

DRUG

Rosuvastatin

20mg / day

DRUG

Placebo

Placebo of rosuvastatin

Sponsors & Collaborators

  • Universidade Federal do Rio de Janeiro

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2020-12-20
Completion
2022-12-20

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03720067 on ClinicalTrials.gov