Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02466854
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2015-06-04
Brief Title:
Bleeding Complications in a Multicenter Registry of Patients Discharged With Diagnosis of Acute Coronary Syndrome
Sponsor:
University of Santiago de Compostela
Organization:
University of Santiago de Compostela
Study Overview
Official Title:
Bleeding Complications in a Multicenter Registry of Patients Discharged With Diagnosis of Acute Coronary Syndrome and Underwent Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2015-06
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:
BleeMACS
Brief Summary:
The BleeMACS Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome registry is an international observational database of bleeding outcomes for patients who are discharged with diagnosis of ACS and underwent Percutaneous Coronary Intervention PCI including myocardial infarction or unstable angina
BleeMACS registry enrolls a total of more than 15000 patients including data from 16 hospitals in 11 countries North America Canada South America Brazil Europe Germany Netherlands Poland Spain Italy Macedonia Greece and Asia Japan and China
The end-point of this study is to characterize patients at high risk of bleeding and to develop a risk score to accurately predict the risk of major bleeding within the first year after discharge from the hospital for an ACS
BleeMACS registry enrolls a total of more than 15000 patients including data from 16 hospitals in 11 countries North America Canada South America Brazil Europe Germany Netherlands Poland Spain Italy Macedonia Greece and Asia Japan and China
The end-point of this study is to characterize patients at high risk of bleeding and to develop a risk score to accurately predict the risk of major bleeding within the first year after discharge from the hospital for an ACS
Detailed Description:
In December 2014 given the actual need for rigorous multicenter clinical investigation to test the safety of antithrombotic and contemporary therapies in patients with acute coronary syndromes ACS Dr Sergio Raposeiras-Roubín and Dr Emad Abu-Assi launched the BleeMACS Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome project
Antithrombotic medication is commonly used for secondary prevention in patients following an ACS This therapy along with the invasive strategies has been proved as effective although it increases the risk of bleeding which may counteract its benefits
A growing body of evidence has demonstrated that the risk of death in patients with ACS is affected not only by recurrent ischemic events but also by major bleeding Bleeding complications is the downside of antithrombotic therapy as they were consistently associated with short- and long-term mortality in addition to increase the risk of new thrombotic events particularly due to temporary or permanent modificationsuspension of antithrombotic therapy which is especially relevant in the first year after an ACS
At present there are several risk scores for predicting bleeding at short-term during the hospitalization stage and at 30 days However at medium and long-term ie 1 year there is no available predicting systems to help clinicians quantify the bleeding risk of their patients How could physicians predict the risk of bleeding after hospital discharge for ACS
The purpose of this project was focused on helping clinicians to estimate the patients baseline risk of major bleeding within the first year following an ACS The investigators aim to identify the independent predictors of major bleeding at 1-year in order to develop a user-friendly bleeding risk score The scoring system that the investigators intended to design using the data from the present registry would help clinicians in the decision-making process by identifying the optimal antithrombotic strategy focusing closer attention to the patients with high risk of bleeding
Antithrombotic medication is commonly used for secondary prevention in patients following an ACS This therapy along with the invasive strategies has been proved as effective although it increases the risk of bleeding which may counteract its benefits
A growing body of evidence has demonstrated that the risk of death in patients with ACS is affected not only by recurrent ischemic events but also by major bleeding Bleeding complications is the downside of antithrombotic therapy as they were consistently associated with short- and long-term mortality in addition to increase the risk of new thrombotic events particularly due to temporary or permanent modificationsuspension of antithrombotic therapy which is especially relevant in the first year after an ACS
At present there are several risk scores for predicting bleeding at short-term during the hospitalization stage and at 30 days However at medium and long-term ie 1 year there is no available predicting systems to help clinicians quantify the bleeding risk of their patients How could physicians predict the risk of bleeding after hospital discharge for ACS
The purpose of this project was focused on helping clinicians to estimate the patients baseline risk of major bleeding within the first year following an ACS The investigators aim to identify the independent predictors of major bleeding at 1-year in order to develop a user-friendly bleeding risk score The scoring system that the investigators intended to design using the data from the present registry would help clinicians in the decision-making process by identifying the optimal antithrombotic strategy focusing closer attention to the patients with high risk of bleeding
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 |
|---|---|---|---|
| Cardiochus | REGISTRY | BleeMACS | None |