Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518317
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Short Versus Long Antiplatelet Therapy After TAVI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Short Versus Long Antiplatelet Therapy After TAVI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
SOLOTAVI
Brief Summary:
The goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months short treatment regimen after percutaneous aortic valve replacement is as safe and efficient as the routine lifetime treatment by aspirin standard treatment regimen
The main questions it aims to answer are
Does the reduction of the duration of aspirin reduces rates of bleeding without increasing the risk of cardiovascular events
Researchers will compare a short treatment by aspirin 3 months to a long treatment by aspirin 12 months after percutaneous replacement of the aortic valve
Participants will
Take aspirin for 3 months in one group or 12 months in another group Be contacted by phone or visit the clinic at 3 4 6 8 10 and 12 months after hospital discharge Keep a diary of any bleeding or cardiovascular events occurring during the study period
The main questions it aims to answer are
Does the reduction of the duration of aspirin reduces rates of bleeding without increasing the risk of cardiovascular events
Researchers will compare a short treatment by aspirin 3 months to a long treatment by aspirin 12 months after percutaneous replacement of the aortic valve
Participants will
Take aspirin for 3 months in one group or 12 months in another group Be contacted by phone or visit the clinic at 3 4 6 8 10 and 12 months after hospital discharge Keep a diary of any bleeding or cardiovascular events occurring during the study period
Detailed Description:
INTRODUCTION AND RATIONALE Aortic stenosis AS is the most common heart valve disease requiring intervention among elderly patients Surgical aortic valve replacement which was the only curative treatment of AS has been challenged during the past decade by the trans-aortic valve implantation TAVI which is becoming the first line treatment of such condition
Antithrombotic therapy after TAVI remains a matter of debate In patients with no indication for antiplatelet therapy aspirin alone is recommended for lifetime However after bioprosthetic surgical valve replacement aspirin is to be discontinued 3 months after surgery and there is no evidence that it should be continued in patients after TAVI with no other indication for such therapy more than half of low risk and a third of intermediate risk TAVI patients Aspirin as compared to placebo in the setting of primary prevention is associated with a 38 relative risk increase of major bleeding in elderly patients with no benefit in terms of mortality or cardiovascular events
Hence there is a major gap of knowledge on whether aspirin is beneficial or harmful if continued more than 3 months as recommended after successful TAVI in absence of another indication as most such patients are elderly and at high bleeding risk
STUDY POPULATION Adult patients with successful transfemoral TAVI for symptomatic aortic stenosis with no indication for long term antiplatelet or anticoagulant therapy This represents approximately 30 of the TAVI patient population
STUDY DESIGN Multicenter open label blinded endpoint assessment randomized non-inferiority trial nested in an ongoing prospective nationwide registry RANDOMIZATION All potentially eligible patients will be included after successful TAVI at hospital discharge to be randomized to receive the experimental or control strategy Randomization will be performed at hospital discharge visit 0 after revision of inclusionexclusion criteria Randomization will be stratified by center and type of valve balloon expandable or self-expandable A hierarchical test procedure will be used for the analysis of the endpoints A hierarchical test procedure will be used for the analysis of the primary and principal secondary endpoints
EXPERIMENTAL ARM Single antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation CONTROL ARM Long term lifetime single antiplatelet therapy75 to 100 mg aspirin therapy after TAVI PRIMARY END POINT Net clinical benefit defined by the composite of all cause death myocardial infarction ischemic or hemorrhagic stroke and major or disabling bleeding assessed at 12 months follow-up NUMBER OF PATIENTS TO BE INCLUDED 1400 700 in each group
Antithrombotic therapy after TAVI remains a matter of debate In patients with no indication for antiplatelet therapy aspirin alone is recommended for lifetime However after bioprosthetic surgical valve replacement aspirin is to be discontinued 3 months after surgery and there is no evidence that it should be continued in patients after TAVI with no other indication for such therapy more than half of low risk and a third of intermediate risk TAVI patients Aspirin as compared to placebo in the setting of primary prevention is associated with a 38 relative risk increase of major bleeding in elderly patients with no benefit in terms of mortality or cardiovascular events
Hence there is a major gap of knowledge on whether aspirin is beneficial or harmful if continued more than 3 months as recommended after successful TAVI in absence of another indication as most such patients are elderly and at high bleeding risk
STUDY POPULATION Adult patients with successful transfemoral TAVI for symptomatic aortic stenosis with no indication for long term antiplatelet or anticoagulant therapy This represents approximately 30 of the TAVI patient population
STUDY DESIGN Multicenter open label blinded endpoint assessment randomized non-inferiority trial nested in an ongoing prospective nationwide registry RANDOMIZATION All potentially eligible patients will be included after successful TAVI at hospital discharge to be randomized to receive the experimental or control strategy Randomization will be performed at hospital discharge visit 0 after revision of inclusionexclusion criteria Randomization will be stratified by center and type of valve balloon expandable or self-expandable A hierarchical test procedure will be used for the analysis of the endpoints A hierarchical test procedure will be used for the analysis of the primary and principal secondary endpoints
EXPERIMENTAL ARM Single antiplatelet therapy 75 to 100 mg aspirin for 3 months after TAVI followed by aspirin discontinuation CONTROL ARM Long term lifetime single antiplatelet therapy75 to 100 mg aspirin therapy after TAVI PRIMARY END POINT Net clinical benefit defined by the composite of all cause death myocardial infarction ischemic or hemorrhagic stroke and major or disabling bleeding assessed at 12 months follow-up NUMBER OF PATIENTS TO BE INCLUDED 1400 700 in each group
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