A Prospective Randomized Study to Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices
Sponsor study identifier
interventional
220
1 country
1
Study Start
June 1, 2015
Actual (reported)Primary Completion
January 31, 2017
Actual (reported)Study Completion
January 31, 2017
Actual (reported)After successful screening of patients based on inclusion criteria, we will measure the baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood investigation including complete haemogram, kidney function test, liver function test, prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan. Routine complete physical examination will be done.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2015
Actual (reported)June 4, 2015
Actual (reported)June 8, 2015
Actual (reported)January 31, 2017
Actual (reported)January 31, 2017
Actual (reported)Total number of patients who will be Responders.
Responders (Absolute value of HVPG\<12 mm Hg or HVPG≥20% reduction)
3 Months
Total number of patients develop esophageal variceal bleed
3 months
Total number of patients develop PHG (Portal Hypertensive Gastropathy).
3 months
Total number of patients develop GAVE (Gastric Antral Vascular Ectasia).
3 months
Total number of patients develop Gastric Varices.
3 months
Total number of patients develop adverse Events of the study drug
3 months
Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min. Simvastatin will be administered orally at a start dose of 20 mg for 15 days followed by 40 mg OD for the next 3 months. Along with Simvastatin, Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.
Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Carvedilol + Simvastatin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordInstitute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Vijayaraghavan R, Jindal A, Arora V, Choudhary A, Kumar G, Sarin SK. Hemodynamic Effects of Adding Simvastatin to Carvedilol for Primary Prophylaxis of Variceal Bleeding: A Randomized Controlled Trial. Am J Gastroenterol. 2020 May;115(5):729-737. doi: 10.14309/ajg.0000000000000551.
Dr V Rajan, MD
Institute of Liver and Biliary Sciences, India
220 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2015
First Posted
June 8, 2015
Study Start
June 1, 2015
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
January 31, 2017
Actual (reported)Study Completion
January 31, 2017
Actual (reported)Last Updated
May 11, 2018
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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