Pulmonary Embolism Clinical Trial
Official title:
A Phase III, Randomized, Open Label Study Evaluating the Safety of Apixaban in Subjects With Cancer Related Venous Thromboembolism
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
PRIMARY OBJECTIVES:
I. Any episode of major bleeding including fatal bleeding.
SECONDARY OBJECTIVES:
I. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary
embolism (PE), fatal PE, or arterial thromboembolism.
II. Any episode of major bleeding including fatal bleeding or any episode of clinically
relevant non-major bleeding.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive apixaban 10 mg orally (PO) twice daily (BID) on days 1-7 and
lower-dose apixaban 5 mg PO BID on days 8-180.
ARM II: Patients receive dalteparin 200 international units (IU)/kg/day subcutaneously (SC)
once daily (QD) on days 1-30 and lower-dose dalteparin 150 IU/kg/day SC QD on days 31-180.
After completion of study treatment, patients are followed up at 3 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05050617 -
Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
|
||
| Terminated |
NCT04558125 -
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism
|
Phase 4 | |
| Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
| Completed |
NCT03915925 -
Short-term Clinical Deterioration After Acute Pulmonary Embolism
|
||
| Completed |
NCT02502396 -
Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
|
||
| Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
| Completed |
NCT04454554 -
Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
|
||
| Completed |
NCT03173066 -
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography
|
Phase 1 | |
| Terminated |
NCT03002467 -
Impact Analysis of Prognostic Stratification for Pulmonary Embolism
|
N/A | |
| Completed |
NCT02611115 -
Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography.
|
N/A | |
| Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
| Completed |
NCT01975090 -
The SENTRY Clinical Study
|
N/A | |
| Not yet recruiting |
NCT01357941 -
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)
|
N/A | |
| Completed |
NCT01326507 -
Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
|
N/A | |
| Completed |
NCT00720915 -
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
|
N/A | |
| Completed |
NCT02476526 -
Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT00780767 -
Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism
|
Phase 2 | |
| Completed |
NCT00771303 -
Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
|
||
| Completed |
NCT00773448 -
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism
|
N/A | |
| Completed |
NCT00244725 -
Odiparcil For The Prevention Of Venous Thromboembolism
|
Phase 2 |