Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 6.25 mg BD. After randomization they will be followed up for one year.
The investigators hypothesized that efficacy of carvedilol is equal to the efficacy of placebo in the pre primary prophylaxis of esophageal varices in cirrhosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis|
- the proportions of patients who develop esophageal varices at 1 year in each group. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- complications of cirrhosis (ascites, hepatic encephalopathy, SBP), [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Number of patient dying in a period of one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Number of patients needing discontinuation of therapy due to adverse effects. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Tablet 6.25 mg BD
Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD.
Placebo Comparator: placebo
Placebo tablets 2 BD
The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212250
|Contact: Shiv Kumar Sarin, DMemail@example.com|
|Institute of Liver & Biliary Sciences (ILBS)||Recruiting|
|New Delhi, Delhi, India|
|Contact: Chitranshu Vashishtha, DM +91-9540951042 firstname.lastname@example.org,|
|Principal Investigator: Chitranshu Vashishtha, MBBS, MD, DM|