Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04007055
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2019-07-01
Brief Title:
The Value of Screening for HPR in Patients Undergoing Lower Extremity Arterial Endovascular Interventions
Sponsor:
Marissa Jarosinski
Organization:
University of Pittsburgh
Study Overview
Official Title:
The Value of Screening for High on Treatment Platelet Reactivity in Patients Undergoing Lower Extremity Arterial Endovascular Interventions
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled trial designed to evaluate the role of screening for and intervening on patients with high on treatment platelet reactivity undergoing lower extremity arterial endovascular interventions
Detailed Description:
Peripheral arterial disease PAD affects millions of people worldwide Management of PAD has evolved from open surgery to an endovascular first approach leading to increased volume of endovascular interventions Endovascular femoropopliteal intervention has emerged as a standard treatment for symptomatic PAD with acceptable patency rates
Histologic observation of bare metal stents with early failure shows association with platelet rich thrombus high counts of platelets and neutrophils associated with stent struts Additionally high inflation pressures associated with balloon angioplasty often causes local tissue damage leading to platelet activation These findings led to studies targeting platelet activation following endovascular treatment showing improved outcomes in patients receiving stronger platelet inhibition
The current standard of care is prescription of dual antiplatelet therapy DAPT for femoropopliteal angioplasty or stenting DAPT is active use of any two antiplatelet agents often low dose aspirin plus P2Y12 inhibitor clopidogrel ticagrelor prasugrel There is improved stent patency and reduced adverse cardiovascular events in patients taking DAPT versus aspirin monotherapy
Clopidogrel is the most common additional antiplatelet agent prescribed but 4-65 of patients taking clopidogrel fail to achieve clinically expected platelet inhibition This persistent platelet reactivity despite compliant antiplatelet use is commonly referred to as high on-treatment platelet reactivity HPR and increases risk of endovascular intervention failure and associated adverse clinical events in these patients Clopidogrel is a pro-drug metabolized by CYP2C19 enzyme into its active form Failure to respond appropriately to clopidogrel is largely due to genetic polymorphisms within CYP2C19 enzyme resulting in variable metabolization of clopidogrel into the active metabolite
Alternative antiplatelet medications can overcome HPR through different metabolic pathways but unfortunately at a significantly higher cost Of these ticagrelor is often used to overcome HPR for patients taking clopidogrel with favorable outcomes However regional cost for ticagrelor is 35250 compared to 196 for clopidogrel Cost and bleeding concerns among providers have prevented widespread use Overall there is paucity of evidence looking at HPR and lower extremity arterial endovascular interventions without consensus or guidelines on how to address this problem Thus the investigators propose an unblinded randomized controlled trial in patients having femoropopliteal angioplasty or stenting comparing two strategies 1 testing and treating for HPR versus 2 guideline based therapy without testing for HPR
Histologic observation of bare metal stents with early failure shows association with platelet rich thrombus high counts of platelets and neutrophils associated with stent struts Additionally high inflation pressures associated with balloon angioplasty often causes local tissue damage leading to platelet activation These findings led to studies targeting platelet activation following endovascular treatment showing improved outcomes in patients receiving stronger platelet inhibition
The current standard of care is prescription of dual antiplatelet therapy DAPT for femoropopliteal angioplasty or stenting DAPT is active use of any two antiplatelet agents often low dose aspirin plus P2Y12 inhibitor clopidogrel ticagrelor prasugrel There is improved stent patency and reduced adverse cardiovascular events in patients taking DAPT versus aspirin monotherapy
Clopidogrel is the most common additional antiplatelet agent prescribed but 4-65 of patients taking clopidogrel fail to achieve clinically expected platelet inhibition This persistent platelet reactivity despite compliant antiplatelet use is commonly referred to as high on-treatment platelet reactivity HPR and increases risk of endovascular intervention failure and associated adverse clinical events in these patients Clopidogrel is a pro-drug metabolized by CYP2C19 enzyme into its active form Failure to respond appropriately to clopidogrel is largely due to genetic polymorphisms within CYP2C19 enzyme resulting in variable metabolization of clopidogrel into the active metabolite
Alternative antiplatelet medications can overcome HPR through different metabolic pathways but unfortunately at a significantly higher cost Of these ticagrelor is often used to overcome HPR for patients taking clopidogrel with favorable outcomes However regional cost for ticagrelor is 35250 compared to 196 for clopidogrel Cost and bleeding concerns among providers have prevented widespread use Overall there is paucity of evidence looking at HPR and lower extremity arterial endovascular interventions without consensus or guidelines on how to address this problem Thus the investigators propose an unblinded randomized controlled trial in patients having femoropopliteal angioplasty or stenting comparing two strategies 1 testing and treating for HPR versus 2 guideline based therapy without testing for HPR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None