Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655376
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients with Assist Device
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Delayed ARIES Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported with a Left Ventricular Assist Device
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heart failure is a world epidemic LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management Improving outcomes have been seen with the newer LVAD technology the HeartMate 3 Abbott Chicago IL however hemocompatibility related adverse events including thrombosis and bleeding are still a major cause of morbidity and mortality The recent ARIES trial showed that in patients with advanced heart failure treated with a HeartMate3 LVAD avoidance of aspirin as part of an antithrombotic regimen which includes vitamin K antagonist VKA is not inferior to a regimen containing aspirin does not increase thromboembolism risk and is associated with a reduction in bleeding events
This clinical investigation is a prospective randomized controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens VKA with and without aspirin The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy
This clinical investigation is a prospective randomized controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens VKA with and without aspirin The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy
Detailed Description:
Objective To study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure who are chronically supported with the HeartMate 3 LVAD
Hypothesis The withdrawal of aspirin from the antithrombotic regimen of HeartMate3 LVAD patients will not adversely affect safety and efficacy and may reduce non-surgical bleeding
Clinical Investigation Design This is a prospective randomized controlled clinical investigation of advanced heart failure patients who are chronically supported with the HeartMate 3 LVAD The study will compare two different antithrombotic regimens VKA with aspirin versus VKA without aspirin
End points
Primary end point
Composite of Survival free of any major hemocompatibility related adverse event at 1-year post randomization
1 Major Hemocompatibility Related Adverse Event Stroke Pump Thrombosis suspected or confirmed major non surgical Bleeding moderate or severe including intracranial bleeds that do not meet the stroke definition Arterial Peripheral Thromboembolism
Secondary end point
Non-surgical Major Hemorrhagic Events
Non-surgical Major Thrombotic Events
Survival
Stroke Rates
Pump Thrombosis Rates
Bleeding Rates including
Non-surgical Bleeding
Moderate Bleeding
Severe Bleeding
Fatal Bleeding
GI Bleeding Descriptive endpoints
Hemocompatibility score
a tiered hierarchal score that weighs each hemocompatibility related adverse event by its escalating clinical relevanceāø
Rehospitalizations
Economic Cost Implications
Subgroup analysis patients with increased bleedingthrombotic risk ie prior HRAE events
Number of Subjects Required for Inclusion in Clinical Investigation
Based on ARIES results 58 patients will need to be enrolled in each arm 116 total to achieve 80 power to prove that the non-aspirin group is non-inferior to the aspirin group using a non-inferiority margin of 15 with the Farrington-Manning risk difference approach to non-inferiority at a one-sided alpha 005 To account for an expected 10 dropout rate up to 128 patients will be randomized in the trial
Hypothesis The withdrawal of aspirin from the antithrombotic regimen of HeartMate3 LVAD patients will not adversely affect safety and efficacy and may reduce non-surgical bleeding
Clinical Investigation Design This is a prospective randomized controlled clinical investigation of advanced heart failure patients who are chronically supported with the HeartMate 3 LVAD The study will compare two different antithrombotic regimens VKA with aspirin versus VKA without aspirin
End points
Primary end point
Composite of Survival free of any major hemocompatibility related adverse event at 1-year post randomization
1 Major Hemocompatibility Related Adverse Event Stroke Pump Thrombosis suspected or confirmed major non surgical Bleeding moderate or severe including intracranial bleeds that do not meet the stroke definition Arterial Peripheral Thromboembolism
Secondary end point
Non-surgical Major Hemorrhagic Events
Non-surgical Major Thrombotic Events
Survival
Stroke Rates
Pump Thrombosis Rates
Bleeding Rates including
Non-surgical Bleeding
Moderate Bleeding
Severe Bleeding
Fatal Bleeding
GI Bleeding Descriptive endpoints
Hemocompatibility score
a tiered hierarchal score that weighs each hemocompatibility related adverse event by its escalating clinical relevanceāø
Rehospitalizations
Economic Cost Implications
Subgroup analysis patients with increased bleedingthrombotic risk ie prior HRAE events
Number of Subjects Required for Inclusion in Clinical Investigation
Based on ARIES results 58 patients will need to be enrolled in each arm 116 total to achieve 80 power to prove that the non-aspirin group is non-inferior to the aspirin group using a non-inferiority margin of 15 with the Farrington-Manning risk difference approach to non-inferiority at a one-sided alpha 005 To account for an expected 10 dropout rate up to 128 patients will be randomized in the trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None