Ignite Creation Date:
2024-05-06 @ 2:05 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01967615
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2013-10-17
Brief Title:
P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI
Sponsor:
G dAnnunzio University
Organization:
G dAnnunzio University
Study Overview
Official Title:
P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI With Biologically Active Stents P2BiTO Registry
Status:
COMPLETED
Status Verified Date:
2017-10
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:
P2BiTO
Brief Summary:
Prasugrel and ticagrelor were both associated with a significant reduction in the risk of MACE in patients undergoing PCI for an ACS mostly through a reduced stent thrombosis The 1-year relative risk reduction RRR of definite of probable stent thrombosis in patients receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials The incidence of biologically active stent DES or BVS thrombosis is largely variable according to different lesion settings We aim to verify the translation of the postulated different reduction in thrombosis rate among various P2Y12 inhibitors clopidogrel prasugrel and ticagrelor in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating lesions
Detailed Description:
All patients aged 18-80 who underwent PCI of a CTO or bifurcating lesion all Medina types side branch 2 mm with biologically active stents DES or BVS between January 2012 and december 2014 at participating centers will be deemed eligible to enter the registry
In-hospital outcomes will be recorded all patients discharged alive will be followed up with a telephone interview minimum follow-up 6 months
The primary end-point will be the occurrence of a cluster of major adverse cardiovascular events at 1 year
1 Death from any cause
2 Myocardial infarction
3 Stent thrombosis defined as definite probable or possible following the Academic Research Consortium
Sample size 3150 patients
In-hospital outcomes will be recorded all patients discharged alive will be followed up with a telephone interview minimum follow-up 6 months
The primary end-point will be the occurrence of a cluster of major adverse cardiovascular events at 1 year
1 Death from any cause
2 Myocardial infarction
3 Stent thrombosis defined as definite probable or possible following the Academic Research Consortium
Sample size 3150 patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-100813 | REGISTRY | P2BiTO | None |