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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.
This pilot study will be a prospective, randomized, controlled, open label, trial of HeartMate 3 (HM3) LVAD patients with 1:1 randomization to either apixaban or warfarin. All patients will be treated with aspirin 81 mg daily as per the LVAD manufacturer instructions for use (IFU).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental | LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily. |
|
| Warfarin | Active Comparator | LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Patients randomized to apixaban will be started on a dose of 5 mg BID. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism) | Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism) | From enrollment to end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Free of Any Stroke | Compared between each study arm | From enrollment to end of treatment at 24 weeks |
| Survival Free of Ischemic Stroke | Compared between each study arm |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Death or Hemocompatibility Related Adverse Events Evaluated in Subgroups of Patients Within 3 Months of Implant Versus Greater Than 3 Months From LVAD Implant | Freedom From Death or Hemocompatibility Related Adverse Events (composite of Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism) evaluated in subgroups of patients within 3 months of implant versus greater than 3 months from LVAD implant |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Palak Shah, MD, MS | Inova Health Care Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37956897 | Background | Dimond M, Looby M, Shah B, Sinha SS, Isseh I, Rollins AT, Abdul-Aziz AA, Kennedy J, Tang DG, Klein KM, Casselman S, Vermeulen C, Sheaffer W, Snipes M, O'connor CM, Shah P. Design and Rationale for the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices (DOAC LVAD) Study. J Card Fail. 2024 Jun;30(6):819-828. doi: 10.1016/j.cardfail.2023.10.473. Epub 2023 Nov 11. | |
| 38795110 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban | LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily. Apixaban: Patients randomized to apixaban will be started on a dose of 5 mg BID. LVAD implant: Subjects will undergo HeartMate 3 LVAD implant prior to randomization |
| FG001 | Warfarin | LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5 Warfarin: Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. LVAD implant: Subjects will undergo HeartMate 3 LVAD implant prior to randomization |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban | LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily. Apixaban: Patients randomized to apixaban will be started on a dose of 5 mg BID. LVAD implant: Subjects will undergo HeartMate 3 LVAD implant prior to randomization |
| BG001 | Warfarin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism) | Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism) | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
From enrollment to final safety visit at 28 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Apixaban | LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily. Apixaban: Patients randomized to apixaban will be started on a dose of 5 mg BID. LVAD implant: Subjects will undergo HeartMate 3 LVAD implant prior to randomization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious AE Infection | Infections and infestations | Systematic Assessment | Infection requiring hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AE Renal and Urinary Disorders | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Palak Shah | Inova Schar Heart and Vascular | 703-776-2213 | palak.shah@inova.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2021 | Oct 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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Open-label, prospective, randomized, 1:1 intervention arm versus control
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| Warfarin |
| Drug |
Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. |
|
| LVAD implant | Device | Subjects will undergo HeartMate 3 LVAD implant prior to randomization |
|
| From enrollment to end of treatment at 24 weeks |
| Survival Free of Hemorrhagic Stroke | Compared between each study arm | From enrollment to end of treatment at 24 weeks |
| Survival Free of Device Thrombosis | Compared between each study arm | From enrollment to end of treatment at 24 weeks |
| Survival Free of Gastrointestinal Bleeding | Compared between each study arm | From enrollment to end of treatment at 24 weeks |
| Survival Free of Major Non-gastrointestinal Bleeding | Compared between each study arm | From enrollment to end of treatment at 24 weeks |
| All-cause Mortality | Compared between each study arm | From enrollment to end of treatment at 24 weeks |
| Cardiovascular Mortality | Compared between each study arm | From enrollment to end of treatment at 24 weeks |
| Survival Free of Aortic Root Thrombus | Compared between each study arm | From enrollment to end of treatment at 24 weeks |
| From enrollment to end of treatment at 24 weeks |
| Result |
| Shah P, Looby M, Dimond M, Bagchi P, Shah B, Isseh I, Rollins AT, Abdul-Aziz AA, Kennedy J, Tang DG, Klein KM, Casselman S, Vermeulen C, Sheaffer W, Snipes M, Sinha SS, O'Connor CM. Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices: The DOAC LVAD Study. JACC Heart Fail. 2024 Sep;12(9):1540-1549. doi: 10.1016/j.jchf.2024.04.013. Epub 2024 May 7. |
LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5 Warfarin: Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. LVAD implant: Subjects will undergo HeartMate 3 LVAD implant prior to randomization |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5
Warfarin: Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5.
LVAD implant: Subjects will undergo HeartMate 3 LVAD implant prior to randomization
|
|
| Secondary | Survival Free of Any Stroke | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Secondary | Survival Free of Ischemic Stroke | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Secondary | Survival Free of Hemorrhagic Stroke | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Secondary | Survival Free of Device Thrombosis | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Secondary | Survival Free of Gastrointestinal Bleeding | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Secondary | Survival Free of Major Non-gastrointestinal Bleeding | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Secondary | All-cause Mortality | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Secondary | Cardiovascular Mortality | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Secondary | Survival Free of Aortic Root Thrombus | Compared between each study arm | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| Other Pre-specified | Freedom From Death or Hemocompatibility Related Adverse Events Evaluated in Subgroups of Patients Within 3 Months of Implant Versus Greater Than 3 Months From LVAD Implant | Freedom From Death or Hemocompatibility Related Adverse Events (composite of Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism) evaluated in subgroups of patients within 3 months of implant versus greater than 3 months from LVAD implant | Posted | Count of Participants | Participants | From enrollment to end of treatment at 24 weeks |
|
|
|
| 0 |
| 16 |
| 7 |
| 16 |
| 14 |
| 16 |
| EG001 | Warfarin | LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5 Warfarin: Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. LVAD implant: Subjects will undergo HeartMate 3 LVAD implant prior to randomization | 0 | 14 | 8 | 14 | 12 | 14 |
|
| Serious AE Cardiac | Cardiac disorders | Systematic Assessment | Hospitalization for heart failure |
|
| Serious AE Gastrointestinal bleeding | Gastrointestinal disorders | Systematic Assessment | Gastrointestinal bleeding, serious |
|
| Serious AE Other | General disorders | Systematic Assessment | Other serious adverse events included in the warfarin group include (1 each): diabetic ketoacidosis, arrhythmia, severed driveline, RV thrombus; Other serious adverse events included in the apixaban group includes (1 each): hypertensive urgency |
|
| Serious AE Device Related | Surgical and medical procedures | Systematic Assessment | Device explant |
|
| AE Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| AE Hematologic | Blood and lymphatic system disorders | Systematic Assessment |
|
| AE Infection | Infections and infestations | Systematic Assessment |
|
| AE Cardiac | Cardiac disorders | Systematic Assessment |
|
| AE Neurologic | Nervous system disorders | Systematic Assessment |
|
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |