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Apixaban or Dalteparin in Reducing Blood Clots in Patients With Cancer Related Venous Thromboembolism
Phase 3 trial testing Apixaban in Cerebral Vein Thrombosis in 300 participants. Completed in 24 December 2019.
| Lead sponsor | Academic and Community Cancer Research United |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 300 |
| Start date | 20 November 2015 |
| Primary completion | 2 April 2018 |
| Estimated completion | 24 December 2019 |
| Sites | 18 locations across United States |
Academic and Community Cancer Research United — full company profile →
18 and older, any sex, with Cerebral Vein Thrombosis or Deep Vein Thrombosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Apixaban) | 0 | 0 – 0 |
| Arm B (Dalteparin) | 2.1 | 0.6 – 6.6 |
A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Apixaban) | 7.0 | 4.1 – 11.9 |
| Arm B (Dalteparin) | 8.1 | 4.7 – 13.9 |
Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE).
| Group | Value | 95% CI |
|---|---|---|
| Arm A (Apixaban) | NA | NA – NA |
| Arm B (Dalteparin) | NA | NA – NA |
Time frame: Up to 3 months after completion of treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm A (Apixaban) | Arm B (Dalteparin) |
|---|---|---|---|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Bleeding | Vascular disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Death NOS | General disorders | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Fracture | Injury, poisoning and procedural complications | — | — |
| Creatinine increased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Pericardial effusion | Cardiac disorders | — | — |
| Colonic perforation | Gastrointestinal disorders | — | — |
| Enterocolitis | Gastrointestinal disorders | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Reaction | System | Arm A (Apixaban) | Arm B (Dalteparin) |
|---|---|---|---|
| Platelet count decreased | Investigations | — | — |
| Bleeding | Vascular disorders | — | — |
| Injection site reaction | General disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Hypertension | Vascular disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Alkaline phosphatase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Pain | General disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Mucosal infection | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Creatinine increased | Investigations | — | — |
| Weight loss | Investigations | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Chronic kidney disease | Renal and urinary disorders | — | — |
| Urinary retention | Renal and urinary disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
Most-reported serious reactions: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify, Bleeding, Lung infection, Sepsis, Abdominal pain, Urinary tract infection, Thromboembolic event, Anemia.
Data from ClinicalTrials.gov NCT02585713 adverse events section.
This randomized phase III trial studies the side effects of and compares apixaban and dalteparin in reducing blood clots in patients with cancer-related venous thromboembolism. Venous thromboembolism is a condition in which a blood clot forms in a vein and then breaks off and moves through the bloodstream. Patients with cancer are at increased risk for venous thromboembolism. Apixaban and dalteparin are drugs used to prevent blood clots from forming or to treat blood clots that have formed. It is not yet known whether apixaban or dalteparin is more effective in reducing blood clots in patients with cancer related venous thromboembolism. ADAM-VTE
8 peer-reviewed publications reference this trial (live from Europe PMC):
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