Efficacy and Safety of Rivaroxaban in Acute Non-neoplastic Portal Vein Thrombosis in HCV
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
Portal vein thrombosis (PVT) in patients with liver cirrhosis may be due to neoplastic growth or non-neoplastic causes.
- Treating PVT with anticoagulation in liver cirrhosis is difficult to be established but may be of great benefit in acute symptomatic PVT.
- The ultimate goal is complete recanalization of the portal vein without inducing major bleeding, abnormal liver function tests or increased mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 26, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedJune 28, 2017
June 1, 2017
2.3 years
May 26, 2017
June 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete recanalization of the portal vein
bedside ultrasonography for detection of thrombus resolution
6 months
Secondary Outcomes (2)
major bleeding
6 months
Hepatotoxicity
6 MONTHS
Other Outcomes (1)
short term survival
1 year
Study Arms (2)
study group
ACTIVE COMPARATORacute non-neoplastic PVT, compensated cirrhosis, acute PVT onset within 1 week after initial diagnosis \- treated with rivaroxaban
control group
PLACEBO COMPARATORacute non-neoplastic PVT, compensated cirrhosis, acute PVT onset within 1 week after initial diagnosis receive placebo
Interventions
Eligibility Criteria
You may qualify if:
- Acute non-neoplastic portal vein thrombosis
- Compensated cirrhosis (Child class A-B)
- The onset of PVT is within 1 week.
You may not qualify if:
- Decompensated liver disease
- Bleeding tendency or recent bleeding event as bleeding peptic ulcer or oesophageal varices
- Neoplastic invasion of the portal vein
- Renal impairment with the creatinine clearance ≤ 30 ml/min
- Pregnancy and breastfeeding
- Hypersensitivity to rivaroxaban
- Concomitant treatment with another anticoagulant
- Concomitant use of clopidogrel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hanafy AS, Abd-Elsalam S, Dawoud MM. Randomized controlled trial of rivaroxaban versus warfarin in the management of acute non-neoplastic portal vein thrombosis. Vascul Pharmacol. 2019 Feb;113:86-91. doi: 10.1016/j.vph.2018.05.002. Epub 2018 Jun 7.
PMID: 29886103DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- open label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
May 26, 2017
First Posted
June 28, 2017
Study Start
May 1, 2014
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
June 28, 2017
Record last verified: 2017-06