DVT: Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis

Sponsor
Beni-Suef University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04462003
Collaborator
(none)
100
1
2
12
8.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Single blind
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.
Actual Study Start Date :
Jul 3, 2019
Anticipated Primary Completion Date :
Jul 2, 2020
Anticipated Study Completion Date :
Jul 3, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Recurrent deep venous thrombosis or venous thromboembolism [6 months]

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

  2. Occurrence of fatal or major bleeding [6 months]

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

  3. Mortality related to massive pulmonary embolism [6 months]

    Death caused by hemodynamic instability secondary to massive pulmonary embolism

Secondary Outcome Measures

  1. Occurrence of non-fatal or minor bleeding [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine,Beni-Suef University Banī Suwayf Beni-Suef Egypt 62511

Sponsors and Collaborators

  • Beni-Suef University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mostafa El Mokadem, Dr, Beni-Suef University
ClinicalTrials.gov Identifier:
NCT04462003
Other Study ID Numbers:
  • Apixaban in DVT with cancer
First Posted:
Jul 8, 2020
Last Update Posted:
Jul 8, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2020