NCT02466854

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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
Last Updated

June 9, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

June 4, 2015

Last Update Submit

June 8, 2015

Conditions

Acute Coronary Syndrome

Keywords

BleedingAcute Coronary Syndromepercutaneous coronary intervention1 year follow up

Outcome Measures

Primary Outcomes (1)

  • Serious bleeding

    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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Zheng W, Huang X, Wang X, Suo M, Yan Y, Gong W, Ai H, Que B, Nie S. Impact of multimorbidity patterns on outcomes and treatment in patients with coronary artery disease. Eur Heart J Open. 2024 Mar 27;4(2):oeae009. doi: 10.1093/ehjopen/oeae009. eCollection 2024 Mar.

    PMID: 38544919DERIVED

  • Zhang D, Gao H, Song X, Raposeiras-Roubin S, Abu-Assi E, Paulo Simao Henriques J, D'Ascenzo F, Saucedo J, Ramon Gonzalez-Juanatey J, Wilton SB, Kikkert WJ, Nunez-Gil I, Ariza-Sole A, Alexopoulos D, Liebetrau C, Kawaji T, Moretti C, Huczek Z, Nie S, Fujii T, Correia L, Kawashiri MA, Southern D, Kalpak O; Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome BleeMACS Registry Investigators. Optimal medical therapy improves outcomes in patients with diabetes mellitus and acute myocardial infarction. Diabetes Res Clin Pract. 2023 Sep;203:110833. doi: 10.1016/j.diabres.2023.110833. Epub 2023 Jul 20.

    PMID: 37478977DERIVED

  • Zhang D, Song X, Raposeiras-Roubin S, Abu-Assi E, Simao Henriques JP, D'Ascenzo F, Saucedo J, Gonzalez-Juanatey JR, Wilton SB, Kikkert WJ, Nunez-Gil I, Ariza-Sole A, Alexopoulos D, Liebetrau C, Kawaji T, Moretti C, Huczek Z, Nie S, Fujii T, Correia L, Kawashiri MA, Southern D, Kalpak O. Evaluation of optimal medical therapy in acute myocardial infarction patients with prior stroke. Ther Adv Chronic Dis. 2021 Sep 29;12:20406223211046999. doi: 10.1177/20406223211046999. eCollection 2021.

    PMID: 34729148DERIVED

  • Raposeiras-Roubin S, Faxen J, Iniguez-Romo A, Henriques JPS, D'Ascenzo F, Saucedo J, Szummer K, Jernberg T, James SK, Juanatey JRG, Wilton SB, Kikkert WJ, Nunez-Gil I, Ariza-Sole A, Song X, Alexopoulos D, Liebetrau C, Kawaji T, Moretti C, Huczek Z, Nie SP, Fujii T, Correia L, Kawashiri MA, Caneiro-Queija B, Cobas-Paz R, Acuna JMG, Southern D, Alfonso E, Terol B, Garay A, Zhang D, Chen Y, Xanthopoulou I, Osman N, Mollmann H, Shiomi H, Giordana F, Gaita F, Kowara M, Filipiak K, Wang X, Yan Y, Fan JY, Ikari Y, Nakahayshi T, Sakata K, Yamagishi M, Kalpak O, Kedev S, Rivera-Asenjo D, Abu-Assi E. Development and external validation of a post-discharge bleeding risk score in patients with acute coronary syndrome: The BleeMACS score. Int J Cardiol. 2018 Mar 1;254:10-15. doi: 10.1016/j.ijcard.2017.10.103. Epub 2018 Jan 28.

    PMID: 29407077DERIVED

  • Iannaccone M, D'Ascenzo F, Vadala P, Wilton SB, Noussan P, Colombo F, Raposeiras Roubin S, Abu Assi E, Gonzalez-Juanatey JR, Simao Henriques JP, Saucedo J, Kikkert WJ, Nunez-Gil I, Ariza-Sole A, Song XT, Alexopoulos D, Liebetrau C, Kawaji T, Moretti C, Garbo R, Huczek Z, Nie SP, Fujii T, Correia LC, Kawashiri MA, Garcia Acuna JM, Southern D, Alfonso E, Terol B, Garay A, Zhang D, Chen Y, Xanthopoulou I, Osman N, Mollmann H, Shiomi H, Giordana F, Kowara M, Filipiak K, Wang X, Yan Y, Fan JY, Ikari Y, Nakahashi T, Sakata K, Gaita F, Yamagishi M, Kalpak O, Kedev S. Prevalence and outcome of patients with cancer and acute coronary syndrome undergoing percutaneous coronary intervention: a BleeMACS substudy. Eur Heart J Acute Cardiovasc Care. 2018 Oct;7(7):631-638. doi: 10.1177/2048872617706501. Epub 2017 Jun 8.

    PMID: 28593789DERIVED

  • Iannaccone M, D Ascenzo F, De Filippo O, Gagliardi M, Southern DA, Raposeiras-Roubin S, Abu-Assi E, Henriques JPS, Saucedo J, Gonzalez-Juanatey JR, Wilton SB, Kikkert WJ, Nunez-Gil I, Ariza-Sole A, Song X, Alexopoulos D, Liebetrau C, Kawaji T, Huczek Z, Nie SP, Fujii T, Correia L, Kawashiri MA, Garcia-Acuna JM, Alfonso E, Terol B, Garay A, Zhang D, Chen Y, Xanthopoulou I, Osman N, Mollmann H, Shiomi H, Kowara M, Filipiak K, Wang X, Yan Y, Fan JY, Ikari Y, Nakahashi T, Sakata K, Yamagishi M, Moretti C, Gaita F, Kalpak O, Kedev S. Optimal Medical Therapy in Patients with Malignancy Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndrome: a BleeMACS Sub-Study. Am J Cardiovasc Drugs. 2017 Feb;17(1):61-71. doi: 10.1007/s40256-016-0196-x.

    PMID: 27738920DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeHemorrhage

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • SERGIO RAPOSEIRAS-ROUBIN, MD, PhD

    University Clinical Hospital of Santiago de Compostela

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 4, 2015

First Posted

June 9, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

June 9, 2015

Record last verified: 2015-06