Bleeding Complications in a Multicenter Registry of Patients Discharged With Diagnosis of Acute Coronary Syndrome (BleeMACS)

June 8, 2015 updated by: SERGIO RAPOSEIRAS ROUBÍN, University of Santiago de Compostela

Bleeding Complications in a Multicenter Registry of Patients Discharged With Diagnosis of Acute Coronary Syndrome and Underwent Percutaneous Coronary Intervention

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 15,000 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.

Study Overview

Status

Completed

Conditions

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 modification/suspension 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 (i.e., ≤ 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 patient's 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 Type

Observational

Enrollment (Actual)

15401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients discharged with diagnosis of Acute Coronary Syndrome underwent percutaneous coronary intervention with at least 1 year of follow-up (except death)

Description

Inclusion Criteria:

  1. Consecutive patients discharged with diagnosis of an Acute Coronary Syndrome (ACS)
  2. Undergoing percutaneous coronary intervention (PCI).
  3. One year follow-up (except death)

Exclusion Criteria:

  1. Patients who died during hospitalization.
  2. Patients without coronary artery disease (basing on the definitions of criteria 2).
  3. Patients who did not undergo PCI (simple balloon angioplasty, stent implantation and/or tromboaspiration).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious bleeding
Time Frame: First year after discharge by acute coronary syndrome
Bleeding requiring hospitalization and/or transfusion within the first year after hospital-discharge by acute coronary syndrome
First year after discharge by acute coronary syndrome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Investigators

  • Study Chair: SERGIO RAPOSEIRAS-ROUBIN, MD, PhD, University Clinical Hospital of Santiago de Compostela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

June 4, 2015

First Submitted That Met QC Criteria

June 8, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USantiago
  • Cardiochus (Registry Identifier: BleeMACS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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