RCT of Carvedilol Versus Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage
RCT of Carvedilol vs Variceal Band Ligation in the Primary Prophylaxis of Oesophageal Variceal Haemorrhage
1 other identifier
interventional
148
1 country
1
Brief Summary
Aim To compare Carvedilol with variceal band ligation in the prevention of first variceal bleed. End points of trial Primary: Variceal hemorrhage Secondary: Death Study design Randomised controlled clinical trial. Results analysed for the above end points on an intention-to-treat basis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2002
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 17, 2010
CompletedFirst Posted
Study publicly available on registry
February 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFebruary 18, 2010
February 1, 2010
8.7 years
February 17, 2010
February 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Variceal hemorrhage
one year
Secondary Outcomes (1)
death
one year
Study Arms (2)
Carvedilol
ACTIVE COMPARATOREach patient will receive Carvedilol 12.5mg QD
Esophageal Variceal Band Ligation
ACTIVE COMPARATOREach patient will undergo for serial esophageal variceal band ligations after 3 weeks of last session till the eradication of varices
Interventions
Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices
Eligibility Criteria
You may qualify if:
- Patients with liver cirrhosis and on endoscopy having grade II, or larger oesophageal varices and who have not bled previously from varices.
You may not qualify if:
- Age \<18 or \> 75 years.
- Pregnant or lactating patients: patients of childbearing age who are not on contraception.
- Allergy to Carvedilol.
- Already on beta blockers or nitrates.
- Presence of malignancy that will significantly affect survival.
- Presence of severe systemic illness e.g. cardiorespiratory, active sepsis.
- Psychiatric disease or learning difficulty that will prevent the granting of informed consent.
- Presence of obstructive airways disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aga Khan University Hospital
Karachi, Sindh, 74800, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Syed hasnain A Shah, MBBS, FRCP
Aga Khan University Hospital, Karachi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 17, 2010
First Posted
February 18, 2010
Study Start
June 1, 2002
Primary Completion
February 1, 2011
Study Completion
July 1, 2011
Last Updated
February 18, 2010
Record last verified: 2010-02