N/A
N=811
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
Cancer · Venous Thromboembolism · Deep Vein Thrombosis (DVT) · Pulmonary Embolism (PE) · Blood Clot
Bottom Line
View on ClinicalTrials.gov: NCT02744092 ↗Enrolled (actual)
811
Serious AEs
39.2%
Results posted
Oct 2023
Primary outcome: Primary: Cumulative Non-Fatal VTE Recurrence at 6 Months (%) — 6.1; 8.8; 7.5; 4.1 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rivaroxaban (Drug); Apixaban (Drug); Edoxaban (Drug); Dabigatran (Drug); Warfarin (Drug); Dalteparin (Drug); Enoxaparin (Drug); Fondaparinux (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance Foundation Trials, LLC.
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Non-Fatal VTE Recurrence at 6 Months (%) |
6.1; 8.8; 7.5; 4.1 | — |
| SECONDARY Cumulative Rates of Major Bleeding |
5.2; 5.6; 11.5; 7.6 | — |
| SECONDARY Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire |
2.4; 0.7; 2.1; -2.8 | — |
| SECONDARY Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire |
56.5; 54.1; 54.9; 53.1 | — |
| SECONDARY Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form) |
21.5; 18.4; 16.3; 23.8 | — |
| SECONDARY Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire |
2.4; 0.7; 2.1; -2.8 | — |
| SECONDARY Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire |
56.5; 54.1; 54.9; 53.1 | — |
| SECONDARY Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire |
11.6; 11.3; 11.5; 10.1 | — |
| SECONDARY Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire |
11.6; 11.3; 11.5; 10.1 | — |
| SECONDARY Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months |
-0.3; 0.7; 0.3; 0.4 | — |
| SECONDARY Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months |
0.3; 0.9; 1.1; -1.9 | — |
Summary
The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma = 18 years
- Platelet count is >= 50, 000/mm^3 ( = 15 ml/min (<= 7 days prior to enrollment)
Exclusion Criteria
- Diagnosis of acute leukemia
- Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
- Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.
- Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible
- Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)
- Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors
- Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment
Data sourced from ClinicalTrials.gov (NCT02744092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.