Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis (DVT)

July 3, 2020 updated by: Mostafa El Mokadem, Beni-Suef University

Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.

The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH). It was hypothesised that Apixaban could be as effective as rivaroxiban and edoxaban in treatment of patients with acute DVT and active malignancy with a lower risk of bleeding especially in those with GIT cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with active malignancy have hypercoagulable state particularly, those receiving intravenous chemotherapy, with six fold higher risk of venous thromboembolism (VTE) [1]. Anticoagulation for malignancy associated deep venous thrombosis (DVT) can be difficult because of different limitations like bleeding, drug-drug interactions with chemotherapy and inconvenience with repeated subcutaneous injections of low-molecular-weight heparin (LMWH) [2]. In comparison with patients without active malignancy, patients with cancer who are on warfarin therapy have 2 to 6 folds more major bleeding events and 2 to 3 times more VTE recurrence [3,4]. The American College of Chest Physicians Guidelines recommended (LMWH) as standard therapy for management of acute VTE in patients with active malignancy [5]. Recently, Rivaroxiban and Edoxaban were considered as an alternative to weight-adjusted subcutaneous LMWH after pulmonary embolism in patients with active cancer without gastrointestinal (GIT) malignancy [6]. Apixaban is a direct factor Xa inhibitor approved by FDA for treatment of DVT and VTE [7]. However its efficacy in management of acute DVT and VTE associated with cancer is still unresolved issue. The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Beni-Suef
      • Banī Suwayf, Beni-Suef, Egypt, 62511
        • Recruiting
        • Faculty of Medicine,Beni-Suef University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mostafa O Mokadem
        • Sub-Investigator:
          • Abd el aziz Z Algaby
        • Sub-Investigator:
          • Ahmed H Shaaban

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria Patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy

Exclusion Criteria:

  • Patients with pulmonary embolism and hemodynamic instability requiring thrombolytic therapy
  • Previous DVT or venous thromboembolism
  • Administration of LMWH or unfractionated heparin before randomization
  • Brain tumours, cerebral metastes, hepatic tumours or impairment Child-Pugh B or C, -Recent or current active or life threating bleeding (e.g. intr acranial haemorrhage or gastrointestinal bleeding)
  • Thrombocytopenia (platelets <100 x 109L)
  • Severe chronic kidney disease (estimated glomerular filtration rate <30 ml/minute)
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Apixaban
50 patients with DVT with malignancy were randomized to apixaban 10 mg twice daily dose for 7 days followed by apixaban 5 mg twice daily
Drug: Apixaban
10 mg/12 h for 1 week followed by 5 mg/12 h
ACTIVE_COMPARATOR: Enoxaparin
50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)
Drug: Enoxaparin
1mg/Kg/sc/12h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent deep venous thrombosis or venous thromboembolism
Time Frame: 6 months
New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism
6 months
Occurrence of fatal or major bleeding
Time Frame: 6 months
Need for hospitalization, blood transfusion, surgical intervention or resulting into death
6 months
Mortality related to massive pulmonary embolism
Time Frame: 6 months
Death caused by hemodynamic instability secondary to massive pulmonary embolism
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of non-fatal or minor bleeding
Time Frame: 6 months
Bleeding that does not need hospitalization, blood transfusion, surgical intervention or resulting into death
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Mostafa E Mokadem, Faculty of Medicine, Beni-suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 3, 2019

Primary Completion (ANTICIPATED)

July 2, 2020

Study Completion (ANTICIPATED)

July 3, 2020

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

July 3, 2020

First Posted (ACTUAL)

July 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 3, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Apixaban in DVT with cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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