Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis.
Key facts
- Where
- New Delhi, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07465471, who can take part
Where in India
- Institute of Liver and Biliary SciencesNew Delhi, IndiaContact: Dr Meenakshi Mann, DNBNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Liver and Biliary Sciences, India
- Trial code
- NCT07465471
- Record updated
- 12 March 2026
- Original description
Acute variceal bleeding (AVB) in cirrhosis occurs as a result of portal hypertension and carries a 6-week mortality rate of approximately 10-20%. Standard management includes a restrictive transfusion approach, vasoactive therapy, prophylactic antibiotics, and endoscopic band ligation. Despite this, early rebleeding within the first 5 days still occurs in about 10-20% of patients, and individuals at particularly high risk may benefit from pre-emptive TIPS. However, its real-world use remains limited; one study reported that only 6.7% of eligible patients actually underwent pre-emptive TIPS, primarily due to logistical challenges and limited interventional radiology availability for early, non-emergent TIPS procedures.Read full original descriptionShow less
Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis: A Randomized Controlled Trial.
Acute variceal bleeding (AVB) in cirrhosis occurs as a result of portal hypertension and carries a 6-week mortality rate of approximately 10-20%. Standard management includes a restrictive transfusion approach, vasoactive therapy, prophylactic antibiotics, and endoscopic band ligation. Despite this, early rebleeding within the first 5 days still occurs in about 10-20% of patients, and individuals at particularly high risk may benefit from pre-emptive TIPS. However, its real-world use remains limited; one study reported that only 6.7% of eligible patients actually underwent pre-emptive TIPS, primarily due to logistical challenges and limited interventional radiology availability for early, non-emergent TIPS procedures.
Midodrine, an oral and fast-acting selective α1-adrenergic agonist, has been shown to enhance the effectiveness of nonselective beta-blockers like propranolol by allowing higher tolerated doses and achieving greater reductions in portal pressure (HVPG), thereby reducing the risk of initial variceal bleeding. However, no studies have evaluated the combination of midodrine with carvedilol-currently a preferred agent-versus carvedilol alone in patients at high risk of rebleeding.
To address this gap, we propose a study comparing carvedilol plus midodrine with carvedilol alone for preventing early rebleeding in cirrhotic patients. Individuals with cirrhosis (Child-Pugh 8-13) presenting with hematemesis will be enrolled, stabilized according to APASL guidelines, and after 48 hours randomized to either combined midodrine-carvedilol therapy or carvedilol alone. Participants will be followed for 6 weeks to assess the incidence of early rebleeding.
Inclusion: Consecutive patients of cirrhosis with high-risk acute variceal bleed (Child-Pugh class B > 7 with active bleeding at initial endoscopy or Child-Pugh class C < 14 points).
Exclusion: Preemptive TIPS or previous Porto-systemic shunt or TIPS; Uncontrolled Hypertension (BP > 140/90 mmHg), heart block, congestive heart failure; Hepatocellular carcinoma (outside Milan criteria), extrahepatic malignancy; Bleeding from isolated gastric or ectopic varices; MELD score >30 and serum lactate >12mmol/L; Age less than 18 years or > 75 years; HR < 60/ min and BP < 100/60 mm Hg; Child-Pugh's score <8 and >13; Refractory variceal bleed; Non-selective Beta blocker/carvedilol / midodrine treatment in last 5 days; Acute kidney injury - HRS; Contraindication to NSBB (HR<60/min, BP<90/60mmHg, bronchial asthma); Pregnant women.