Acute Coronary SyndromeBleeMACSNCT02466854
Bleeding Complications in a Multicenter Registry of Patients Discharged With Diagnosis of Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by University of Santiago de Compostela.
Trial 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)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 15,401 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients discharged with diagnosis of Acute Coronary Syndrome underwent percutaneous coronary intervention with at least 1 year of follow-up (except death)
Who may be able to join
- Consecutive patients discharged with diagnosis of an Acute Coronary Syndrome (ACS)
- Undergoing percutaneous coronary intervention (PCI).
- One year follow-up (except death)
Who cannot join
- 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).
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Bleeding, Acute Coronary Syndrome, percutaneous coronary intervention, 1 year follow up
- Medical subject headings
- Acute Coronary Syndrome, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious bleeding
Bleeding requiring hospitalization and/or transfusion within the first year after hospital-discharge by acute coronary syndrome
Measured: First year after discharge by acute coronary syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO RAPOSEIRAS ROUBÍN, University of Santiago de Compostela
- Investigators
- SERGIO RAPOSEIRAS-ROUBIN, MD, PhD, Study chair, University Clinical Hospital of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466854
- Sponsor's protocol ID
- USantiago
- Other IDs
- Cardiochus
- Acronym
- BleeMACS
- Status last verified
- Jun 2015
- First submitted
- 4 Jun 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38544919Zhang 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.
PubMed 37478977Zhang 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.
PubMed 34729148Raposeiras-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.
PubMed 29407077Iannaccone 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.
PubMed 28593789Iannaccone 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.
PubMed 27738920
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleeding Complications in a Multicenter Registry of Patients Discharged With Diagnosis of Acute Coronary Syndrome and Underwent Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02466854
- Acronym / sponsor ID
- BleeMACS / USantiago
- Conditions
- Acute Coronary Syndrome
- Keywords
- Bleeding, Acute Coronary Syndrome, percutaneous coronary intervention, 1 year follow up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,401 participants (actual)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients discharged with diagnosis of Acute Coronary Syndrome underwent percutaneous coronary intervention with at least 1 year of follow-up (except death)
Key inclusion criteria (3 listed)
- Consecutive patients discharged with diagnosis of an Acute Coronary Syndrome (ACS)
- Undergoing percutaneous coronary intervention (PCI).
- One year follow-up (except death)
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Derived from this study: PubMed 38544919Zheng 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.
- Derived from this study: PubMed 37478977Zhang 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.
- Derived from this study: PubMed 34729148Zhang 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.
- Derived from this study: PubMed 29407077Raposeiras-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.
- Derived from this study: PubMed 28593789Iannaccone 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.
- Derived from this study: PubMed 27738920Iannaccone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SERGIO RAPOSEIRAS-ROUBIN, MD, PhD study chair
University Clinical Hospital of Santiago de Compostela
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by University of Santiago de Compostela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious bleeding (time frame: First year after discharge by acute coronary syndrome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02466854, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.