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A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism

NCT03139487 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2020-01-06

No results posted yet for this study

Summary

This is an open label, multi-center, and randomized phase II trial designed to compare the safety and efficacy of direct oral anticoagulants and subcutaneous dalteparin in patients with acute venous thromboembolism and upper gastrointestinal, hepatobiliary, or pancreatic cancer, based on a group sequential design. Enrolled patients will be randomized in a 1:1 ratio. Patients will be stratified by performance status, type of cancer, chemotherapy and medical centers.

Conditions

  • Cancer-associated Thrombosis
  • Esophageal Cancer
  • Stomach Cancer
  • Hepatocellular Carcinoma
  • Pancreatic Cancer
  • Duodenal Cancer
  • Esophagogastric Junction Cancer
  • Malignant Gastrointestinal Stromal Tumor
  • Ampulla of Vater Cancer
  • Biliary Cancer (Cholangiocarcinoma, Gall Bladder Cancer)

Interventions

DRUG

Rivaroxaban

15 mg q12 hours for 3 weeks followed by 20mg q24 hours for 21 weeks

DRUG

Dalteparin

200 IU/kg q24 hours for 4 weeks followed by 150 IU/kg q24 hours for 20 weeks

DRUG

apixaban

10 mg q12 hours for 7days followed by 5mg q12 hours for 21 weeks

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-07
Primary Completion
2021-09-30
Completion
2021-09-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03139487 on ClinicalTrials.gov