Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06198673
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-26
Brief Title:
A Prospective muLticEnter Registry in chrONic coronARy synDrOme
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Real-world Patterns of Anti-platelet Management in Stable Angina Patients Undergoing Percutaneous Coronary Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
LEONARDO
Brief Summary:
In patients with chronic coronary syndrome CCS clopidogrel has a class IA indication in patients undergoing elective percutaneous coronary intervention PCI Although unproven the possibility exists that clopidogrel does not yield an optimal platelet inhibition in multiple real-world scenarios that challenge current recommendations
The aim of this prospective observational study io assess in a consecutive unselected series of patients with CCS undergoing elective PCI the frequency of the following real world clinical scenarios
No pretreatment at time of PCI naïve
Evidence of incomplete responsiveness to clopidogrel
Indication to a complex PCI
We expect to demonstrate
A not negligible proportion of patients with CCS are naïve at time of elective PCI in clinical practice and require a rapid onset of P2Y12 inhibition
A substantial proportion of patients with CCS who are treated with clopidogrel prior to elective PCI have high platelet responsiveness at time of the procedure
A complex PCI is performed in a substantial proportion of patients with CCS
The aim of this prospective observational study io assess in a consecutive unselected series of patients with CCS undergoing elective PCI the frequency of the following real world clinical scenarios
No pretreatment at time of PCI naïve
Evidence of incomplete responsiveness to clopidogrel
Indication to a complex PCI
We expect to demonstrate
A not negligible proportion of patients with CCS are naïve at time of elective PCI in clinical practice and require a rapid onset of P2Y12 inhibition
A substantial proportion of patients with CCS who are treated with clopidogrel prior to elective PCI have high platelet responsiveness at time of the procedure
A complex PCI is performed in a substantial proportion of patients with CCS
Detailed Description:
In patients with chronic coronary syndrome CCS clopidogrel has a class IA indication in patients undergoing elective percutaneous coronary intervention PCI Figure 1 Initiation of oral P2Y12 inhibitors is usually delayed until the coronary anatomy is defined Knuuti Levine Clopidogrel administered as a 600 mg loading dose followed by a 75 mg maintenance dose is the P2Y12 inhibitor of choice in CCS patients undergoing PCI Knuuti Levine Also pre-treatment with clopidogrel is currently recommended if the probability of PCI is high II BC Although unproven the possibility exists that clopidogrel does not yield an optimal platelet inhibition in multiple real-world scenarios that challenge current recommendations as follows
P2Y12 inhibitors naive patients with CCS who have an indication to PCI after coronary angiography might experience deferral of PCI because they are not pre-treated with clopidogrel Selvarajah 2021
Heterogeneity in individual response profiles to clopidogrel with a considerable number of patients yielding inadequate platelet inhibitory effects might result in increased risk of thrombotic events post-PCI Galli Individual responsiveness to P2Y12 inhibitors can be assessed through platelet function testing Franchi but its implementation in clinical practice is currently not recommended As a consequence a significant proportion of CCS patients are not on a fully effective dual antiplatelet therapy DAPT at time of PCI
Complex PCIs are increasingly performed in CCS patients Complex PCI is commonly defined by any of the following characteristics 3 drug eluting stents implanted bifurcation PCI with 2 stents left main coronary artery PCI saphenous vein graft PCI total stent length 60 mm or chronic total occlusion as target lesion Figure 2 Importantly patients who undergo complex PCI have a substantially higher ischemic risk with increased procedural complexity Giustino Genereaux Preliminary observations suggest that an intensive periprocedural platelet inhibition even on top of DAPT pretreatment might be of benefit in stable patients undergoing percutaneous revascularization of complex lesions Marchese
To assess in a consecutive unselected series of patients with CCS undergoing elective PCI the frequency of the following real world clinical scenarios
No pretreatment at time of PCI naïve
Evidence of incomplete responsiveness to clopidogrel
Indication to a complex PCI Consecutive patients with CCS undergoing elective PCI
Patients will be grouped as follows
Pre-treatment with clopidogrel before elective PCI
Patients receiving a clopidogrel loading at time of elective PCI in the cath lab Patients receiving cangrelor during PCI in the cath lab and then receiving a P2Y12 inhibitor afterwards
Patients with CCS undergoing elective PCI
Patients written informed and privacy consent obtained before the PCI procedure
Male or female patients 18 to 80 years old
Assessment of response to anti-platelet agents by VerifyNowTM
Patients with active bleeding
Patients with hypersensitivity to any anti-platelet agents or to any of its excipients
Known pregnancy or breast-feeding female patients 1000 patients Multicenter evaluation
Pre-treatment with clopidogrel before elective PCI
Patients receiving a clopidogrel loading at time of elective PCI in the cath lab
Patients receiving cangrelor during PCI in the cath lab and then receiving a P2Y12 inhibitor afterwards
1-year
1 Frequency of naive patients with CCS undergoing elective PCI
2 Frequency of complex coronary intervention in patients undergoing elective PCI
Frequency of incomplete response to clopidogrel prior to elective PCI as assessed by VerifyNow TM
Frequency of the use of periprocedural iv cangrelor
Frequency of the use of glycoprotein IIbIIIa GPIIbIIIa inhibitors
Frequency of the use of clopidogrel ticagrelor or prasugrel loading dose
Mode of administration of oral P2Y12 inhibitors crushed
Incidence of post-PCI ischemic complications
Incidence of any post-PCI bleeding according to the Bleeding Academic Research Consortium BARC criteria
Incidence of major adverse cardiac events MACE - MACE will comprise any of the following events death myocardial infarction MI ischemia-driven revascularisation IDR and stent thrombosis ST
Enrolment phase 1 year
Follow-up 1-year
The study will be conducted in accordance with the Declaration of Helsinki on ethical principles for medical research involving human subjects
Informed consent to be included in this survey is mandatory for collecting individual data and must be obtained from all subjects andor their legal representatives as per local regulations
We expect to demonstrate
A not negligible proportion of patients with CCS are naïve at time of elective PCI in clinical practice and require a rapid onset of P2Y12 inhibition
A substantial proportion of patients with CCS who are treated with clopidogrel prior to elective PCI have high platelet responsiveness at time of the procedure
A complex PCI is performed in a substantial proportion of patients with CCS
P2Y12 inhibitors naive patients with CCS who have an indication to PCI after coronary angiography might experience deferral of PCI because they are not pre-treated with clopidogrel Selvarajah 2021
Heterogeneity in individual response profiles to clopidogrel with a considerable number of patients yielding inadequate platelet inhibitory effects might result in increased risk of thrombotic events post-PCI Galli Individual responsiveness to P2Y12 inhibitors can be assessed through platelet function testing Franchi but its implementation in clinical practice is currently not recommended As a consequence a significant proportion of CCS patients are not on a fully effective dual antiplatelet therapy DAPT at time of PCI
Complex PCIs are increasingly performed in CCS patients Complex PCI is commonly defined by any of the following characteristics 3 drug eluting stents implanted bifurcation PCI with 2 stents left main coronary artery PCI saphenous vein graft PCI total stent length 60 mm or chronic total occlusion as target lesion Figure 2 Importantly patients who undergo complex PCI have a substantially higher ischemic risk with increased procedural complexity Giustino Genereaux Preliminary observations suggest that an intensive periprocedural platelet inhibition even on top of DAPT pretreatment might be of benefit in stable patients undergoing percutaneous revascularization of complex lesions Marchese
To assess in a consecutive unselected series of patients with CCS undergoing elective PCI the frequency of the following real world clinical scenarios
No pretreatment at time of PCI naïve
Evidence of incomplete responsiveness to clopidogrel
Indication to a complex PCI Consecutive patients with CCS undergoing elective PCI
Patients will be grouped as follows
Pre-treatment with clopidogrel before elective PCI
Patients receiving a clopidogrel loading at time of elective PCI in the cath lab Patients receiving cangrelor during PCI in the cath lab and then receiving a P2Y12 inhibitor afterwards
Patients with CCS undergoing elective PCI
Patients written informed and privacy consent obtained before the PCI procedure
Male or female patients 18 to 80 years old
Assessment of response to anti-platelet agents by VerifyNowTM
Patients with active bleeding
Patients with hypersensitivity to any anti-platelet agents or to any of its excipients
Known pregnancy or breast-feeding female patients 1000 patients Multicenter evaluation
Pre-treatment with clopidogrel before elective PCI
Patients receiving a clopidogrel loading at time of elective PCI in the cath lab
Patients receiving cangrelor during PCI in the cath lab and then receiving a P2Y12 inhibitor afterwards
1-year
1 Frequency of naive patients with CCS undergoing elective PCI
2 Frequency of complex coronary intervention in patients undergoing elective PCI
Frequency of incomplete response to clopidogrel prior to elective PCI as assessed by VerifyNow TM
Frequency of the use of periprocedural iv cangrelor
Frequency of the use of glycoprotein IIbIIIa GPIIbIIIa inhibitors
Frequency of the use of clopidogrel ticagrelor or prasugrel loading dose
Mode of administration of oral P2Y12 inhibitors crushed
Incidence of post-PCI ischemic complications
Incidence of any post-PCI bleeding according to the Bleeding Academic Research Consortium BARC criteria
Incidence of major adverse cardiac events MACE - MACE will comprise any of the following events death myocardial infarction MI ischemia-driven revascularisation IDR and stent thrombosis ST
Enrolment phase 1 year
Follow-up 1-year
The study will be conducted in accordance with the Declaration of Helsinki on ethical principles for medical research involving human subjects
Informed consent to be included in this survey is mandatory for collecting individual data and must be obtained from all subjects andor their legal representatives as per local regulations
We expect to demonstrate
A not negligible proportion of patients with CCS are naïve at time of elective PCI in clinical practice and require a rapid onset of P2Y12 inhibition
A substantial proportion of patients with CCS who are treated with clopidogrel prior to elective PCI have high platelet responsiveness at time of the procedure
A complex PCI is performed in a substantial proportion of patients with CCS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None