Trial Outcomes & Findings for Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding (NCT NCT02504723)

NCT ID: NCT02504723

Last Updated: 2017-08-21

Results Overview

Rebleeding from gastric varices during the follow-up period

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 121 participants
• Primary outcome timeframe: Within 6 years
• Results posted on: 2017-08-21

Participant Flow

Participant milestones

Measure	Cyanoacrylate Injection Plus Carvedilol The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.	Cyanoacrylate Injection The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
Overall Study STARTED	60	61
Overall Study COMPLETED	60	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Cyanoacrylate Injection Plus Carvedilol n=60 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.	Cyanoacrylate Injection n=61 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.	Total n=121 Participants Total of all reporting groups
Age, Continuous	56.52 years STANDARD_DEVIATION 10.87 • n=60 Participants	56.26 years STANDARD_DEVIATION 12.08 • n=61 Participants	56.39 years STANDARD_DEVIATION 11.45 • n=121 Participants
Sex: Female, Male Female	19 Participants n=60 Participants	20 Participants n=61 Participants	39 Participants n=121 Participants
Sex: Female, Male Male	41 Participants n=60 Participants	41 Participants n=61 Participants	82 Participants n=121 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Within 6 years

Rebleeding from gastric varices during the follow-up period

Outcome measures

Measure	Cyanoacrylate Injection Plus Carvedilol n=60 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.	Cyanoacrylate Injection n=61 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
Rebleeding From Gastric Varices	14 Participants	21 Participants

SECONDARY outcome

Timeframe: Within 6 years

All upper gastrointestinal bleeding during the follow-up period

Outcome measures

Measure	Cyanoacrylate Injection Plus Carvedilol n=60 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.	Cyanoacrylate Injection n=61 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
All Upper Gastrointestinal Bleeding	17 Participants	29 Participants

SECONDARY outcome

Timeframe: Within 6 years

All cause mortality or liver transplantation during the study period

Outcome measures

Measure	Cyanoacrylate Injection Plus Carvedilol n=60 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.	Cyanoacrylate Injection n=61 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
All Cause Mortality or Liver Transplantation	13 Participants	20 Participants

SECONDARY outcome

Timeframe: Within 6 years

All adverse effects during the study period

Outcome measures

Measure	Cyanoacrylate Injection Plus Carvedilol n=60 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.	Cyanoacrylate Injection n=61 Participants The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
All Adverse Effects	32 Participants	9 Participants

Adverse Events

Cyanoacrylate Injection Plus Carvedilol

Serious events: 0 serious events

Other events: 32 other events

Deaths: 12 deaths

Cyanoacrylate Injection

Serious events: 0 serious events

Other events: 9 other events

Deaths: 19 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cyanoacrylate Injection Plus Carvedilol n=60 participants at risk The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. Oral carvedilol is administrated during the whole study period, starting at 6.25 mg daily and increased until the maximum tolerated dose. carvedilol: Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure \>90 mm Hg. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.	Cyanoacrylate Injection n=61 participants at risk The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices. cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
General disorders dizziness	18.3% 11/60 • Number of events 11 • 6 years	1.6% 1/61 • Number of events 1 • 6 years
General disorders weakness	3.3% 2/60 • Number of events 2 • 6 years	1.6% 1/61 • Number of events 1 • 6 years
General disorders hypotension	3.3% 2/60 • Number of events 2 • 6 years	0.00% 0/61 • 6 years
General disorders fatigue	1.7% 1/60 • Number of events 1 • 6 years	0.00% 0/61 • 6 years
General disorders abdominal pain	1.7% 1/60 • Number of events 1 • 6 years	3.3% 2/61 • Number of events 2 • 6 years
General disorders insomnia	3.3% 2/60 • Number of events 2 • 6 years	1.6% 1/61 • Number of events 1 • 6 years
General disorders chronic cough	1.7% 1/60 • Number of events 1 • 6 years	0.00% 0/61 • 6 years
General disorders dyspnea on exertion	13.3% 8/60 • Number of events 8 • 6 years	0.00% 0/61 • 6 years
Gastrointestinal disorders poor gastric ulcer healing	1.7% 1/60 • Number of events 1 • 6 years	3.3% 2/61 • Number of events 2 • 6 years
Gastrointestinal disorders dysphagia	5.0% 3/60 • Number of events 3 • 6 years	0.00% 0/61 • 6 years
Infections and infestations recurrent bacteremia	0.00% 0/60 • 6 years	1.6% 1/61 • Number of events 1 • 6 years
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/60 • 6 years	1.6% 1/61 • Number of events 1 • 6 years

Additional Information

Dr. Wen-Chi Chen

Kaohsiung Veterans General Hospital

Phone: 886-7-3422121

Email: wcchen@vghks.gov.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place