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

NCT03240120 | Unknown Phase 3

• 1 other identifier: HKU-OTI-01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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

Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Number of patients with symptomatic VTE

  first episode of objectively documented symptomatic recurrent VTE (deep vein thrombosis, pulmonary embolism)

  up to 2 years

Secondary Outcomes (1)

• number of mortality, clinically relevant major and non-major bleeding

  up to 2 years

Study Arms (1)

Dabigatran etexilate & Tinzaparin

EXPERIMENTAL

Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed dabigatran 150mg twice daily from Day 6 onward till 6 months after underlying disease remission.

Drug: Dabigatran etexilate; Drug: Tinzaparin

Interventions

Dabigatran etexilate DRUG

Pradaxa 150 mg hard capsules

Also known as: Pradaxa

Dabigatran etexilate & Tinzaparin

Tinzaparin DRUG

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

Dabigatran etexilate & Tinzaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are aged 18 years or above;
• have acute symptomatic deep vein thrombosis or pulmonary embolism with objective confirmation;
• have active cancer, which is defined as a diagnosis of cancer other than basal cell or squamous cell carcinoma of skin within six months before enrollment, any treatment for cancer within the previous six months or recurrent or metastatic cancer.
• Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

You may not qualify if:

• have Eastern Cooperative Oncology Group (ECOG) performance status score of \> 2 at the time of randomization;
• have life expectancy of less than 3 months;
• have active bleeding, are at high risk of bleeding, or have contraindications to anticoagulant treatment;
• receive thrombectomy or fibrinolytic agent to treat the current episode of VTE;
• receive more than 72 hours pre-treatment with therapeutic dosages of anticoagulant treatment prior to randomization to treat the current VTE episode;
• are already on long term oral anticoagulation;
• are on low molecular weight heparin for indications other than VTE;
• have platelet count of less than 100 x 109/L;
• are on dual antiplatelet therapy;
• have a serum creatinine level of more than 220 umol/L or have a calculated creatinine clearance (CrCl) of less than 30 ml/min;
• have alanine aminotransferase level more than 2 times the upper limit of normal range or cirrhosis;
• have history of heparin induced thrombocytopenia;
• are on treatment of potent inhibitors or inducers of P-glycoprotein.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Interventions

Dabigatran; Tinzaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Gloria Hwang, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Hwang, MBBS

CONTACT

852 22553111; yyhwang922@gmail.com

Crosby Lu, MMedSc

CONTACT

852 22553111; khlu@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 4, 2017
• Study Start: September 1, 2017
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

HK (1)