Trial Outcomes & Findings for Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices (NCT NCT04865978)

NCT ID: NCT04865978

Last Updated: 2024-11-14

Results Overview

Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: From enrollment to end of treatment at 24 weeks
• Results posted on: 2024-11-14

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	16	14
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	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	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
Overall Study One patient did not complete the study due to infection and device explant	1	0

Baseline Characteristics

Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices

Baseline characteristics by cohort

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Total n=30 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	56 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race or Ethnic Group · White	11 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Black	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race or Ethnic Group · Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism)	16 Participants	12 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Survival Free of Any Stroke	16 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Survival Free of Ischemic Stroke	16 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Survival Free of Hemorrhagic Stroke	16 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Survival Free of Device Thrombosis	16 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Survival Free of Gastrointestinal Bleeding	16 Participants	12 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Survival Free of Major Non-gastrointestinal Bleeding	16 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
All-cause Mortality	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Cardiovascular Mortality	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From enrollment to end of treatment at 24 weeks

Compared between each study arm

Outcome measures

Measure	Apixaban n=16 Participants 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	Warfarin n=14 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	Warfarin, Less Than 3 Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Survival Free of Aortic Root Thrombus	16 Participants	14 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to end of treatment at 24 weeks

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

Outcome measures

Measure	Apixaban n=8 Participants 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	Warfarin n=8 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	Warfarin, Less Than 3 Months Since LVAD Implantation n=6 Participants Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization	Warfarin, 3 or More Months Since LVAD Implantation n=8 Participants Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5. Subjects will undergo HeartMate 3 LVAD implant prior to randomization
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	8 Participants	8 Participants	5 Participants	7 Participants

Adverse Events

Apixaban

Serious events: 7 serious events

Other events: 14 other events

Deaths: 0 deaths

Warfarin

Serious events: 8 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Apixaban n=16 participants at risk 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	Warfarin n=14 participants at risk 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
Infections and infestations Serious AE Infection	25.0% 4/16 • Number of events 5 • From enrollment to final safety visit at 28 weeks	21.4% 3/14 • Number of events 3 • From enrollment to final safety visit at 28 weeks
Cardiac disorders Serious AE Cardiac	12.5% 2/16 • Number of events 2 • From enrollment to final safety visit at 28 weeks	7.1% 1/14 • Number of events 1 • From enrollment to final safety visit at 28 weeks
Gastrointestinal disorders Serious AE Gastrointestinal bleeding	0.00% 0/16 • From enrollment to final safety visit at 28 weeks	21.4% 3/14 • Number of events 4 • From enrollment to final safety visit at 28 weeks
General disorders Serious AE Other	6.2% 1/16 • Number of events 1 • From enrollment to final safety visit at 28 weeks	28.6% 4/14 • Number of events 4 • From enrollment to final safety visit at 28 weeks
Surgical and medical procedures Serious AE Device Related	6.2% 1/16 • Number of events 1 • From enrollment to final safety visit at 28 weeks	0.00% 0/14 • From enrollment to final safety visit at 28 weeks

Other adverse events

Measure	Apixaban n=16 participants at risk 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	Warfarin n=14 participants at risk 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
Renal and urinary disorders AE Renal and Urinary Disorders	6.2% 1/16 • Number of events 1 • From enrollment to final safety visit at 28 weeks	0.00% 0/14 • From enrollment to final safety visit at 28 weeks
Musculoskeletal and connective tissue disorders AE Musculoskeletal	37.5% 6/16 • Number of events 6 • From enrollment to final safety visit at 28 weeks	7.1% 1/14 • Number of events 1 • From enrollment to final safety visit at 28 weeks
Blood and lymphatic system disorders AE Hematologic	62.5% 10/16 • Number of events 17 • From enrollment to final safety visit at 28 weeks	21.4% 3/14 • Number of events 3 • From enrollment to final safety visit at 28 weeks
Infections and infestations AE Infection	37.5% 6/16 • Number of events 7 • From enrollment to final safety visit at 28 weeks	28.6% 4/14 • Number of events 4 • From enrollment to final safety visit at 28 weeks
Cardiac disorders AE Cardiac	56.2% 9/16 • Number of events 9 • From enrollment to final safety visit at 28 weeks	57.1% 8/14 • Number of events 9 • From enrollment to final safety visit at 28 weeks
Nervous system disorders AE Neurologic	18.8% 3/16 • Number of events 3 • From enrollment to final safety visit at 28 weeks	7.1% 1/14 • Number of events 1 • From enrollment to final safety visit at 28 weeks

Additional Information

Dr. Palak Shah

Inova Schar Heart and Vascular

Phone: 703-776-2213

Email: palak.shah@inova.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place