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

Primary Purpose

Deep Vein Thrombosis, Malignancy

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Apixaban

Enoxaparin

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Medicine,Beni-Suef UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Apixaban

Enoxaparin

Arm Description

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

50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)

Outcomes

Primary Outcome Measures

Recurrent deep venous thrombosis or venous thromboembolism

New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism

Occurrence of fatal or major bleeding

Need for hospitalization, blood transfusion, surgical intervention or resulting into death

Mortality related to massive pulmonary embolism

Death caused by hemodynamic instability secondary to massive pulmonary embolism

Secondary Outcome Measures

Occurrence of non-fatal or minor bleeding

Bleeding that does not need hospitalization, blood transfusion, surgical intervention or resulting into death

Full Information

NCT ID

NCT04462003

First Posted

June 29, 2020

Last Updated

July 3, 2020

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT04462003

Brief Title

Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis

Acronym

DVT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 3, 2019 (Actual)

Primary Completion Date

July 2, 2020 (Anticipated)

Study Completion Date

July 3, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Vein Thrombosis, Malignancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

Single blind

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apixaban

Arm Type

Active Comparator

Arm Description

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

Arm Title

Enoxaparin

Arm Type

Active Comparator

Arm Description

50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)

Intervention Type

Drug

Intervention Name(s)

Apixaban

Intervention Description

10 mg/12 h for 1 week followed by 5 mg/12 h

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

1mg/Kg/sc/12h

Primary Outcome Measure Information:

Title

Recurrent deep venous thrombosis or venous thromboembolism

Description

New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism

Time Frame

6 months

Title

Occurrence of fatal or major bleeding

Description

Need for hospitalization, blood transfusion, surgical intervention or resulting into death

Time Frame

6 months

Title

Mortality related to massive pulmonary embolism

Description

Death caused by hemodynamic instability secondary to massive pulmonary embolism

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Occurrence of non-fatal or minor bleeding

Description

Bleeding that does not need hospitalization, blood transfusion, surgical intervention or resulting into death

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa O Mokadem

Phone

00201009414408

mostafa.elmokadem9@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Abd el aziz Z Algaby

Phone

00201227563870

zizogaby@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mostafa E Mokadem

Organizational Affiliation

Faculty of Medicine, Beni-Suef University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine,Beni-Suef University

City

Banī Suwayf

State/Province

Beni-Suef

ZIP/Postal Code

62511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mostafa O Mokadem

Phone

00201009414408

mostafa.elmokadem9@gmail.com

Ext

Mokadem

mostafa.elmokadem9@gmail.com

First Name & Middle Initial & Last Name & Degree

Mostafa O Mokadem

First Name & Middle Initial & Last Name & Degree

Abd el aziz Z Algaby

First Name & Middle Initial & Last Name & Degree

Ahmed H Shaaban

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10737280

Citation

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Results Reference

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Citation

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Results Reference

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Citation

Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Buller HR. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol. 2000 Sep;18(17):3078-83. doi: 10.1200/JCO.2000.18.17.3078.

Results Reference

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Citation

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26867832

Citation

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Citation

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Mokadem ME, Hassan A, Algaby AZ. Efficacy and safety of apixaban in patients with active malignancy and acute deep venous thrombosis. Vascular. 2021 Oct;29(5):745-750. doi: 10.1177/1708538120971148. Epub 2020 Nov 5.

Results Reference

derived

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Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis

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