Direct Oral Novel Anticoagulants for Patients With High-risk Gastroesophageal Variceal Bleeding and Portal Vein Thrombosis

Fudan University

Status

Not yet enrolling

Conditions

Variceal Bleeding

Portal Vein Thrombosis

Anticoagulant Therapy

Treatments

Drug: Rivaroxaban

Study type

Interventional

Funder types

Other

Identifiers

NCT07602062

KY2026028

Details and patient eligibility

About

This study aims to explore the safety and efficacy of oral administration of a novel anticoagulant (rivaroxaban) in patients with cirrhosis accompanied by high-risk esophagogastric variceal bleeding and portal vein thrombosis, through a prospective, multicenter, randomized controlled clinical trial, starting 48 hours after endoscopic treatment to prevent rebleeding.

Enrollment

175 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical and imaging diagnosis of liver cirrhosis and esophagogastric varices, with at least one previous episode of esophagogastric variceal bleeding
Combined with portal vein thrombosis and D-dimer > 0.8mg/L
Endoscopic evaluation reveals a high risk of variceal bleeding, and endoscopic treatment is performed to prevent rebleeding of esophagogastric varices
Signed informed consent form

Exclusion criteria

Received other antithrombotic therapies before (including warfarin, aspirin, low-molecular-weight heparin, etc.)
Combined with hepatocellular carcinoma or other malignancy
Combined with portal cavernoma
Combined with severe life-threatening diseases of circulatory, hematological and respiratory system
Combined with diseases requiring anticoagulant therapy, such as acute portal vein thrombosis, atrial fibrillation, lower extremity venous thrombosis, and pulmonary embolism
Received TIPS or liver transplantation or splenectomy
With contraindications to anticoagulant therapy (uncontrollable active bleeding, severe hepatic insufficiency, renal insufficiency, etc.)
Currently taking immunosuppressive agents, or medications that affect cytochrome P450 (including azole antifungals and protease inhibitors), or strong inducers of CYP3A4 (including rifampicin, phenytoin, carbamazepine, etc.)