Ignite Creation Date:
2024-05-06 @ 7:11 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02484924
Status:
COMPLETED
Last Update Posted:
2022-06-09
First Post:
2015-06-26
Brief Title:
The Risk of Major Bleeding With Novel Anti-platelets A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome
Sponsor:
Liverpool University Hospitals NHS Foundation Trust
Organization:
Liverpool University Hospitals NHS Foundation Trust
Study Overview
Official Title:
The Risk of Major Bleeding With Novel Anti-platelets A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2016-01
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:
ROBOT-ACS
Brief Summary:
A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients
Detailed Description:
Major bleeding after myocardial infarction portends a poor outcome A balance is required between potency of platelet inhibition and risk of bleeding Ticagrelor provides faster and more effective platelet inhibition than Clopidogrel In the PLATO trial Ticagrelor reduced the incidence of cardiovascular death myocardial infarction and stroke compared to Clopidogrel after ACS acute coronary syndrome Although there was no difference in overall bleeding there was more non-CABG related major bleeding with Ticagrelor It has since been recommended in addition to aspirin in treatment of moderate-high risk ACS by both ESC European Society of Cardiology and NICE National Institute for Clinical Excellence There has been widespread adoption as first line therapy in UK hospitals There remains potential concern about bleeding in a real world population compromising more high risk patients particularly more elderly and female than those in PLATO The investigators intend to perform a large real world comparison of bleeding risk with Ticagrelor compared to Clopidogrel in a UK ACS population The investigators plan an observational cohort study of patients presenting with ACS at 5 district general hospitals in Merseyside and Cheshire The investigators will collect data retrospectively on 2500 patients treated with Clopidogrel prior to the guideline change and 2500 treated with Ticagrelor thereafter The primary end point will be incidence of BARC 3-5 Bleeding Academic Research Consortium and PLATO major bleeding
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