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A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism

NCT03240120 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2019-04-17

No results posted yet for this study

Summary

This trial aims at determining if dabigatran is effective in the treatment of malignancy associated VTE. Tolerance and safety of dabigatran will also be assessed.

This is a single armed trial of dabigatran in patients with malignancy associated VTE.

The target recruitment is 99 consecutive patients with active malignancy and newly diagnosed VTE (deep vein thrombosis and/or pulmonary embolism) in Queen Mary Hospital.

Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed (duplex Doppler ultrasonography for deep vein thrombosis, and computed tomography for pulmonary embolism), and a written consent is obtained. Patients will be switched to dabigatran 150mg twice daily from day 6 onwards. The first dose of dabigatran will be given within 2 hours before the time that the next dose of tinzaparin would have been due. Anticoagulation will be continued as long as malignancy is active. If patients achieve a complete remission of their underlying malignancies, dabigatran will be continued for 6 months further.

Conditions

Interventions

DRUG

Dabigatran etexilate

Pradaxa 150 mg hard capsules

DRUG

Tinzaparin

Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Gloria Hwang, MBBS · The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2021-05-31
Completion
2021-12-31

Countries

  • Hong Kong

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 NCT03240120 on ClinicalTrials.gov