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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02465645 |
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Date of registration:
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04/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.
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Scientific title:
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A Prospective Randomized Study to Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices |
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Date of first enrolment:
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June 1, 2015 |
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Target sample size:
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220 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02465645 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr V Rajan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute of Liver and Biliary Sciences |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. All patients of chronic liver disease with esophageal varices.
2. Age more than and equal to 18 years.
Exclusion Criteria:
1. Patients of chronic liver disease with history of upper Gastro Intestinal bleed.
2. Patients of acute on chronic liver failure
3. Thrombosis of splenoportal axis
4. Hepatocellular carcinoma
5. Patients who were on primary variceal ligation sessions as prophylaxis
6. Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia).
7. Patients who are contraindicated for beta blockers {H/O COPD (Coronary Obstructive
Pulmonary Disease), heart block, refractory Ascites, SBP(Spontaneous Bacterial
Peritonitis) , HRS(Hepato Renal Syndrome)}.
8. Failure to give consent for inclusion in the study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cirrhosis With Esophageal Varices
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Intervention(s)
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Drug: Carvedilol
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Drug: Carvedilol + Simvastatin
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Primary Outcome(s)
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Total number of patients who will be Responders.
[Time Frame: 3 Months]
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Secondary Outcome(s)
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Total number of patients develop GAVE (Gastric Antral Vascular Ectasia).
[Time Frame: 3 months]
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Total number of patients develop Gastric Varices.
[Time Frame: 3 months]
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Total number of patients develop adverse Events of the study drug
[Time Frame: 3 months]
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Total number of patients develop PHG (Portal Hypertensive Gastropathy).
[Time Frame: 3 months]
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Improvement in the CTP (Child-Turcotte-Pugh score) score.
[Time Frame: 3 months]
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Improvement in the MELD (Model for End Stage liver Disease) score.
[Time Frame: 3 months]
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Total number of patients develop esophageal variceal bleed
[Time Frame: 3 months]
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Secondary ID(s)
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ILBS-Cirrhosis-004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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