Not provided
Not provided
Not provided
Not provided
Lack of enrollment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.
Determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. Determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. An exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent Venous Thromboembolism (VTEs) as a secondary objective.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | Active Comparator | Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 |
|
| Apixaban | Active Comparator | Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily |
|
| Rivaroxaban | Active Comparator | Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Clinically Relevant Bleeding Events | Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB)) | Randomization to 12 months |
| Number of Subjects With Recurrent Venous Thromboembolism (VTE) | Primary efficacy outcome of recurrent VTE | Randomization to 12 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Experiencing Major Bleeding | Major bleeding | Randomization to 12 months |
| Number of Subjects Experiencing Clinically Relevant Non-major Bleeding | Clinically relevant non-major bleeding |
3.1 Inclusion Criteria
To be eligible for this trial, patients must meet all of the following criteria:
3.2 Exclusion Criteria
If a patient meets any of the following criteria, he or she may not be enrolled in the study:
Diagnosed with cancer within the past 6 months; or Recurrent, regionally advanced or metastatic disease; Currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or A hematologic malignancy not in complete remission
• Unwilling / unlikely to agree to follow up
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Ortel, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Warfarin | Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3 |
| FG001 | Apixaban | Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily |
| FG002 | Rivaroxaban | Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
44 subjects were randomized yet only 31 were on study drug by the 1 month telephone follow up. Due to the study being stopped early some of the data was outstanding in the database which is why the numbers do not add up to 44 in all of the categories.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Warfarin | Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3 |
| BG001 | Apixaban |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Clinically Relevant Bleeding Events | Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB)) | 44 subjects were randomized but analysis was only done on participants that had started therapy by the 1 month telephone visit | Posted | Count of Participants | Participants | Randomization to 12 months |
|
Up to 9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Warfarin | Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Warfarin: Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Ortel | Duke University | 919-684-5350 ext 3 | thomas.ortel@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2018 | Jul 9, 2019 | SAP_002.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 21, 2018 | Jul 9, 2019 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2018 | Jul 9, 2019 | ICF_004.pdf |
Not provided
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014859 | Warfarin |
| C522181 | apixaban |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Apixaban 2.5 MG | Drug | Will be randomized to receive open label apixaban of 2.5 mg twice daily |
|
| Rivaroxaban 10 MG | Drug | Will be randomized to receive open label rivaroxaban of 10mg daily |
|
| Randomization to 12 months |
| Number of Subjects With Premature Termination of Study Medication | Premature termination of study medication | Randomization to 12 months |
| Number of Subjects Experiencing All-cause Mortality | All cause mortality | Randomization to 12 months |
| Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke) | MI, ischemic stroke, peripheral arterial embolism | Randomization to 12 months |
| Study Terminated early |
|
Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily |
| BG002 | Rivaroxaban | Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | In the Apixaban arm 1 subject was never administered study drug and in the rivaroxaban 2 subjects never received study drug. They were excluded from the analysis. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily
Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily
| OG002 | Rivaroxaban | Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily |
|
|
| Primary | Number of Subjects With Recurrent Venous Thromboembolism (VTE) | Primary efficacy outcome of recurrent VTE | Posted | Count of Participants | Participants | Randomization to 12 months |
|
|
|
| Other Pre-specified | Number of Subjects Experiencing Major Bleeding | Major bleeding | Posted | Count of Participants | Participants | Randomization to 12 months |
|
|
|
| Other Pre-specified | Number of Subjects Experiencing Clinically Relevant Non-major Bleeding | Clinically relevant non-major bleeding | Posted | Count of Participants | Participants | Randomization to 12 months |
|
|
|
| Other Pre-specified | Number of Subjects With Premature Termination of Study Medication | Premature termination of study medication | Posted | Count of Participants | Participants | Randomization to 12 months |
|
|
|
| Other Pre-specified | Number of Subjects Experiencing All-cause Mortality | All cause mortality | Posted | Count of Participants | Participants | Randomization to 12 months |
|
|
|
| Other Pre-specified | Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke) | MI, ischemic stroke, peripheral arterial embolism | Posted | Count of Participants | Participants | Randomization to 12 months |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Apixaban | Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Apixaban 2.5 MG: Will be randomized to receive open label apixaban of 2.5 mg twice daily | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Rivaroxaban | Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Rivaroxaban 10 MG: Will be randomized to receive open label rivaroxaban of 10mg daily | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|