Myocardial FibrosisPhase 4BATTLE-AMINCT02428374
Role of Immune Responses After Acute Myocardial Infarction
A Phase 4 study testing Rosuvastatin plus clopidogrel, Rosuvastatin plus ticagrelor and Simvastatin plus clopidogrel in people with Myocardial Fibrosis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The fascinating role of lymphocyte subtypes in the development of coronary artery disease may be a new strategic target for understanding and therapy of acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Fibrosis
- What is being tested?
- Rosuvastatin plus clopidogrel, Rosuvastatin plus ticagrelor and Simvastatin plus clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Jul 2019
- Phase
- Phase 4
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Stable patients with ST elevation myocardial infarction (STEMI) treated with thrombolytics in the first 6h or the initial of symptoms of MI.
Who cannot join
- Contraindication or known intolerance to the study drug protocol
- Those with comorbidities such as neoplasm, renal insufficiency (stage 4 or higher)
- Patients should be randomized in the first 24 hours of AMI and treated by one of the four combined therapies at least 2h prior to coronary angiogram followed by percutaneous intervention when necessary.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Sao Paulo - UNIFESP
São Paulo, São Paulo, 04040001
Francisco A H Fonseca, MD, PhD, +5511992639082, fahfonseca@terra.com.br
About this study
Official title: Role of Innate and Adaptive Immunity After Acute Myocardial Infarction BATTLE-AMI Study (B And T Types of Lymphocytes Evaluation in Acute Myocardial Infarction)
The fascinating role of lymphocyte subtypes in the development of coronary artery disease may be a new strategic target for understanding and therapy of acute myocardial infarction. The determinants of cell viability are unknown, postulating that they arise from factors not only related to microcirculation or energy expenditure, but also to inflammatory and immune responses. Furthermore, the intense mobilization of progenitor cells secondary to myocardial infarction triggers large lymphocyte proliferation that colonizes plaques in development, contributing to recurrent ischemic outcomes. This project aims to evaluate the immune and metabolic mechanisms involved in the recovery of the ischemic myocardium and coronary disease progression.
Read the detailed description
Specifically, the investigators will study the innate and adaptive immunity, with emphasis on lymphocytes subtypes involved in the early and late surrogate outcomes of patients with acute myocardial infarction, their characterization (B1, B2 and T lymphocytes) in cell culture and by flow-cytometry, and immune responses (IgM and IgG for oxLDL and specific epitopes of apoB). In addition, the project will evaluate new biomarkers identified by studies of metabolomics, as well as the corresponding signaling pathways. Therapeutic pharmacological strategies and changes on intestinal microbiota will be evaluated since the acute phase of myocardial infarction up to 6 months.
In the study, the investigators will compared four arms of combined therapy: clopidogrel with rosuvastatin; or clopidogrel with simvastatin; or ticagrelor with rosuvastatin; or ticagrelor with simvastatin. The investigator's hypothesis is that the improvement of microcirculation with rosuvastatin and ticagrelor (synergic pleiotropic effects) may decrease the infarcted mass area, resulting in better left ventricular ejection fraction when compared to the other combined therapies.
The monitoring and genotype of microbiota will be examined together the metabolomics and cardiac MRIs obtained at the acute phase of MI and after 1-mo and 6-mo FU.
- Conditions
- Myocardial Fibrosis
- Being tested
- Rosuvastatin plus clopidogrel, Rosuvastatin plus ticagrelor, Simvastatin plus clopidogrel, Simvastatin plus ticagrelor
- Keywords
- MRI, Ventricular function, left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin plus clopidogrelDrug
Also called Crestor & Plavix
Crestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo
Rosuvastatin plus ticagrelorDrug
Also called Crestor & Brilinta
Crestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo
Simvastatin plus clopidogrelDrug
Also called Zocor plus Plavix
Zocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo
Simvastatin plus ticagrelorDrug
Also called Zocor & Brilinta
Zocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo
| Study group | Role | What they receive |
|---|---|---|
| rosuvastatin plus clopidogrel | Active comparator | rosuvastatin 40 mg and clopidogrel 75 mg Receives: Drug: Rosuvastatin plus ticagrelor; Drug: Simvastatin plus clopidogrel; Drug: Simvastatin plus ticagrelor |
| Rosuvastatin plus ticagrelor | Active comparator | Rosuvastatin 40 mg plus ticagrelor 90 mg bid Receives: Drug: Rosuvastatin plus clopidogrel; Drug: Simvastatin plus clopidogrel; Drug: Simvastatin plus ticagrelor |
| simvastatin plus clopidogrel | Active comparator | Simvastatin 40 mg plus clopidogrel 75 mg Receives: Drug: Rosuvastatin plus clopidogrel; Drug: Rosuvastatin plus ticagrelor; Drug: Simvastatin plus ticagrelor |
| Simvastatin plus ticagrelor | Active comparator | Simvastatin 40 mg plus ticagrelor 90 mg bid Receives: Drug: Rosuvastatin plus clopidogrel; Drug: Rosuvastatin plus ticagrelor; Drug: Simvastatin plus clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the left ventricular function (MRI) between the four combined treatments, after STEMI
The effects of treatments on the left ventricular function will be measured by MRI
Measured: 1-mo
Secondary outcomes (15)
To compare the effects of the four combined therapies on the left ventricular function after STEMI
Variables will be examined by MRI
Measured: 3-d
To compare the effects of the four combined therapies on the left ventricular function after STEMI
Variables will be examined by MRI
Measured: 6-mo
To compare the effects of the four combined therapies on the infarcted mass area after STEMI
Variables will be examined by MRI
Measured: 1-mo
To compare the effects of the four combined therapies on the infarcted mass area after STEMI
Variables will be examined by MRI
Measured: 6-mo
To compare the effects of the four combined therapies on the percentage of subjects with left ventricular ejection fraction < 40% after STEMI
Variables will be examined by MRI
Measured: 1-mo
To compare the effects of the four combined therapies on the percentage of subjects with left ventricular ejection fraction < 40% after STEMI
Variables will be examined by MRI
Measured: 6-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI
Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI
Measured: 1-d
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI
Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI
Measured: 1-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI
Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI
Measured: 6-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI
Lymphocyte subtypes quantified by flow-cytometry and infarcted mass area by MRI
Measured: 1-d
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI
Lymphocyte subtypes quantified by flow-cytometry and infarcted mass area by MRI
Measured: 1-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI
Lymphocyte subtypes quantified by flow-cytometry and infarcted mass area by MRI
Measured: 6-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI
Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI
Measured: 1-d
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI
Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI
Measured: 1-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI
Lymphocyte subtypes quantified by flow-cytometry and left ventricular ejection fraction by MRI
Measured: 6-mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (120)Papers the sponsor has linked to this study.
- Other trials for Myocardial FibrosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Francisco Antonio Helfenstein Fonseca, Federal University of São Paulo
- Investigators
- Francisco A Fonseca, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428374
- Sponsor's protocol ID
- EPM/UNIFESP
- Other IDs
- FAPESP
- Acronym
- BATTLE-AMI
- Status last verified
- Jun 2015
- First submitted
- 10 Mar 2015
- Last updated
- 11 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fonseca FA, Izar MC, Fuster V, Gallo R, Padurean A, Fallon JT, Schachter EN, Chesebro JH, Badimon JJ. Chronic endothelial dysfunction after oversized coronary balloon angioplasty in pigs: a 12-week follow-up of coronary vasoreactivity in vivo and in vitro. Atherosclerosis. 2001 Jan;154(1):61-9. doi: 10.1016/s0021-9150(00)00458-5.
PubMed 11137083Silva EP, Fonseca FA, Ihara SS, Izar MC, Lopes IL, Pinto LE, Badimon JJ, Tuffik S, Paiva TB, Kasinski N, de Paola AV, Carvalho AC. Early benefits of pravastatin to experimentally induced atherosclerosis. J Cardiovasc Pharmacol. 2002 Mar;39(3):389-95. doi: 10.1097/00005344-200203000-00010.
PubMed 11862118Fonseca FA, Paiva TB, Silva EG, Ihara SS, Kasinski N, Martinez TL, Filho EE. Dietary magnesium improves endothelial dependent relaxation of balloon injured arteries in rats. Atherosclerosis. 1998 Aug;139(2):237-42. doi: 10.1016/s0021-9150(98)00069-0.
PubMed 9712329Fonseca FA, Ihara SS, Izar MC, Silva EP, Kasinski N, Lopes IE, Pinto LE, Paiva TB, Tufik S, de Paola AA, Carvalho AC. Hydrochlorothiazide abolishes the anti-atherosclerotic effect of quinapril. Clin Exp Pharmacol Physiol. 2003 Oct;30(10):779-85. doi: 10.1046/j.1440-1681.2003.03911.x.
PubMed 14516418Ferreira WP, Bertolami MC, Santos SN, Barros MR, de Matos Barretto RB, Pontes SC Jr, Fonseca FH, Carvalho AC. One-month therapy with simvastatin restores endothelial function in hypercholesterolemic children and adolescents. Pediatr Cardiol. 2007 Jan-Feb;28(1):8-13. doi: 10.1007/s00246-005-1304-x. Epub 2007 Jan 25.
PubMed 17318708Monteiro CM, Pinheiro LF, Izar MC, Barros SW, Vasco MB, Fischer SM, Povoa RM, Brandao SA, Santos AO, Oliveira L, Carvalho AC, Fonseca FA. Highly sensitive C-reactive protein and male gender are independently related to the severity of coronary disease in patients with metabolic syndrome and an acute coronary event. Braz J Med Biol Res. 2010 Mar;43(3):297-302. doi: 10.1590/s0100-879x2010005000008. Epub 2010 Mar 5.
PubMed 20209376da Silva EF, Fonseca FA, Franca CN, Ferreira PR, Izar MC, Salomao R, Camargo LM, Tenore SB, Lewi DS. Imbalance between endothelial progenitors cells and microparticles in HIV-infected patients naive for antiretroviral therapy. AIDS. 2011 Aug 24;25(13):1595-601. doi: 10.1097/QAD.0b013e32834980f4.
PubMed 21673561Franca CN, Pinheiro LF, Izar MC, Brunialti MK, Salomao R, Bianco HT, Kasmas SH, Barbosa SP, de Nucci G, Fonseca FA. Endothelial progenitor cell mobilization and platelet microparticle release are influenced by clopidogrel plasma levels in stable coronary artery disease. Circ J. 2012;76(3):729-36. doi: 10.1253/circj.cj-11-1145. Epub 2011 Dec 28.
PubMed 22214900Pomaro DR, Ihara SS, Pinto LE, Ueda I, Casarini DE, Ebihara F, Santos AO, Izar MC, Fonseca FA. High glucose levels abolish antiatherosclerotic benefits of ACE inhibition in alloxan-induced diabetes in rabbits. J Cardiovasc Pharmacol. 2005 Apr;45(4):295-300. doi: 10.1097/01.fjc.0000155384.64350.45.
PubMed 15772516Relvas WG, Izar MC, Segreto HR, Giordani AJ, Ihara SS, Mariano M, Lopes JD, Popi AF, Helfenstein T, Pomaro D, Povoa RM, Carvalho AC, Fonseca FA. Resident peritoneal inflammatory cells are pivotal in the development of experimental atherosclerosis. J Atheroscler Thromb. 2010 Apr 30;17(4):378-85. doi: 10.5551/jat.3418. Epub 2010 Mar 9.
PubMed 20215709Helfenstein T, Fonseca FA, Ihara SS, Bottos JM, Moreira FT, Pott H Jr, Farah ME, Martins MC, Izar MC. Impaired glucose tolerance plus hyperlipidaemia induced by diet promotes retina microaneurysms in New Zealand rabbits. Int J Exp Pathol. 2011 Feb;92(1):40-9. doi: 10.1111/j.1365-2613.2010.00753.x.
PubMed 21272105Feio CA, Izar MC, Ihara SS, Kasmas SH, Martins CM, Feio MN, Maues LA, Borges NC, Moreno RA, Povoa RM, Fonseca FA. Euterpe oleracea (acai) modifies sterol metabolism and attenuates experimentally-induced atherosclerosis. J Atheroscler Thromb. 2012;19(3):237-45. doi: 10.5551/jat.11205. Epub 2011 Dec 3.
PubMed 22139433Albert MA, Glynn RJ, Fonseca FA, Lorenzatti AJ, Ferdinand KC, MacFadyen JG, Ridker PM. Race, ethnicity, and the efficacy of rosuvastatin in primary prevention: the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial. Am Heart J. 2011 Jul;162(1):106-14.e2. doi: 10.1016/j.ahj.2011.03.032. Epub 2011 Jun 12.
PubMed 21742096de Lima Sanches P, de Mello MT, Elias N, Fonseca FA, de Piano A, Carnier J, Oyama LM, Tock L, Tufik S, Damaso AR. Improvement in HOMA-IR is an independent predictor of reduced carotid intima-media thickness in obese adolescents participating in an interdisciplinary weight-loss program. Hypertens Res. 2011 Feb;34(2):232-8. doi: 10.1038/hr.2010.225. Epub 2010 Dec 2.
PubMed 21124323Fonseca FA, Franca CN, Povoa RM, Izar MC. [Statins and stroke: potential mechanisms for neurovascular protection]. Rev Neurol. 2010 Nov 1;51(9):551-60. Spanish.
PubMed 20979035
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Innate and Adaptive Immunity After Acute Myocardial Infarction BATTLE-AMI Study (B And T Types of Lymphocytes Evaluation in Acute Myocardial Infarction)
- ClinicalTrials.gov ID
- NCT02428374
- Acronym / sponsor ID
- BATTLE-AMI / EPM/UNIFESP
- Conditions
- Myocardial Fibrosis
- Keywords
- MRI, Ventricular function, left
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 28 Apr 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 fascinating role of lymphocyte subtypes in the development of coronary artery disease may be a new strategic target for understanding and therapy of acute myocardial infarction. The determinants of cell viability are unknown, postulating that they arise from factors not only related to microcirculation or energy expenditure, but also to inflammatory and immune responses. Furthermore, the intense mobilization of progenitor cells secondary to myocardial infarction triggers large lymphocyte proliferation that colonizes plaques in development, contributing to recurrent ischemic outcomes. This project aims to evaluate the immune and metabolic mechanisms involved in the recovery of the ischemic myocardium and coronary disease progression.
Detailed description
Specifically, the investigators will study the innate and adaptive immunity, with emphasis on lymphocytes subtypes involved in the early and late surrogate outcomes of patients with acute myocardial infarction, their characterization (B1, B2 and T lymphocytes) in cell culture and by flow-cytometry, and immune responses (IgM and IgG for oxLDL and specific epitopes of apoB). In addition, the project will evaluate new biomarkers identified by studies of metabolomics, as well as the corresponding signaling pathways. Therapeutic pharmacological strategies and changes on intestinal microbiota will be evaluated since the acute phase of myocardial infarction up to 6 months.
In the study, the investigators will compared four arms of combined therapy: clopidogrel with rosuvastatin; or clopidogrel with simvastatin; or ticagrelor with rosuvastatin; or ticagrelor with simvastatin. The investigator's hypothesis is that the improvement of microcirculation with rosuvastatin and ticagrelor (synergic pleiotropic effects) may decrease the infarcted mass area, resulting in better left ventricular ejection fraction when compared to the other combined therapies.
The monitoring and genotype of microbiota will be examined together the metabolomics and cardiac MRIs obtained at the acute phase of MI and after 1-mo and 6-mo FU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rosuvastatin plus clopidogrel | Active comparator | Drug: Rosuvastatin plus ticagrelor, Drug: Simvastatin plus clopidogrel, Drug: Simvastatin plus ticagrelorrosuvastatin 40 mg and clopidogrel 75 mg |
| Rosuvastatin plus ticagrelor | Active comparator | Drug: Rosuvastatin plus clopidogrel, Drug: Simvastatin plus clopidogrel, Drug: Simvastatin plus ticagrelorRosuvastatin 40 mg plus ticagrelor 90 mg bid |
| simvastatin plus clopidogrel | Active comparator | Drug: Rosuvastatin plus clopidogrel, Drug: Rosuvastatin plus ticagrelor, Drug: Simvastatin plus ticagrelorSimvastatin 40 mg plus clopidogrel 75 mg |
| Simvastatin plus ticagrelor | Active comparator | Drug: Rosuvastatin plus clopidogrel, Drug: Rosuvastatin plus ticagrelor, Drug: Simvastatin plus clopidogrelSimvastatin 40 mg plus ticagrelor 90 mg bid |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Stable patients with ST elevation myocardial infarction (STEMI) treated with thrombolytics in the first 6h or the initial of symptoms of MI.
Key exclusion criteria (3 listed)
- Contraindication or known intolerance to the study drug protocol
- Those with comorbidities such as neoplasm, renal insufficiency (stage 4 or higher)
- Patients should be randomized in the first 24 hours of AMI and treated by one of the four combined therapies at least 2h prior to coronary angiogram followed by percutaneous intervention when necessary.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin plus clopidogrelAlso: Crestor & PlavixCrestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo | Drug | Rosuvastatin plus ticagrelor, Simvastatin plus ticagrelor, simvastatin plus clopidogrel |
| Rosuvastatin plus ticagrelorAlso: Crestor & BrilintaCrestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo | Drug | Simvastatin plus ticagrelor, rosuvastatin plus clopidogrel, simvastatin plus clopidogrel |
| Simvastatin plus clopidogrelAlso: Zocor plus PlavixZocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo | Drug | Rosuvastatin plus ticagrelor, Simvastatin plus ticagrelor, rosuvastatin plus clopidogrel |
| Simvastatin plus ticagrelorAlso: Zocor & BrilintaZocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo | Drug | Rosuvastatin plus ticagrelor, rosuvastatin plus clopidogrel, simvastatin plus clopidogrel |
Primary outcome
Comparison of the left ventricular function (MRI) between the four combined treatments, after STEMI
Time frame: 1-mo
The effects of treatments on the left ventricular function will be measured by MRI
15 secondary outcomes
To compare the effects of the four combined therapies on the left ventricular function after STEMI
Time frame: 3-d
To compare the effects of the four combined therapies on the left ventricular function after STEMI
Time frame: 6-mo
To compare the effects of the four combined therapies on the infarcted mass area after STEMI
Time frame: 1-mo
To compare the effects of the four combined therapies on the infarcted mass area after STEMI
Time frame: 6-mo
To compare the effects of the four combined therapies on the percentage of subjects with left ventricular ejection fraction < 40% after STEMI
Time frame: 1-mo
To compare the effects of the four combined therapies on the percentage of subjects with left ventricular ejection fraction < 40% after STEMI
Time frame: 6-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI
Time frame: 1-d
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI
Time frame: 1-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction after STEMI
Time frame: 6-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI
Time frame: 1-d
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI
Time frame: 1-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with infarcted mass area after STEMI
Time frame: 6-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI
Time frame: 1-d
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI
Time frame: 1-mo
To quantify the percentage and absolute number of B1, B2, TCD4, and TCD8 subtypes of lymphocytes and their correlation with left ventricular ejection fraction <40% after STEMI
Time frame: 6-mo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Background: PubMed 11137083Fonseca FA, Izar MC, Fuster V, Gallo R, Padurean A, Fallon JT, Schachter EN, Chesebro JH, Badimon JJ. Chronic endothelial dysfunction after oversized coronary balloon angioplasty in pigs: a 12-week follow-up of coronary vasoreactivity in vivo and in vitro. Atherosclerosis. 2001 Jan;154(1):61-9. doi: 10.1016/s0021-9150(00)00458-5.
- Background: PubMed 11862118Silva EP, Fonseca FA, Ihara SS, Izar MC, Lopes IL, Pinto LE, Badimon JJ, Tuffik S, Paiva TB, Kasinski N, de Paola AV, Carvalho AC. Early benefits of pravastatin to experimentally induced atherosclerosis. J Cardiovasc Pharmacol. 2002 Mar;39(3):389-95. doi: 10.1097/00005344-200203000-00010.
- Background: PubMed 9712329Fonseca FA, Paiva TB, Silva EG, Ihara SS, Kasinski N, Martinez TL, Filho EE. Dietary magnesium improves endothelial dependent relaxation of balloon injured arteries in rats. Atherosclerosis. 1998 Aug;139(2):237-42. doi: 10.1016/s0021-9150(98)00069-0.
- Background: PubMed 14516418Fonseca FA, Ihara SS, Izar MC, Silva EP, Kasinski N, Lopes IE, Pinto LE, Paiva TB, Tufik S, de Paola AA, Carvalho AC. Hydrochlorothiazide abolishes the anti-atherosclerotic effect of quinapril. Clin Exp Pharmacol Physiol. 2003 Oct;30(10):779-85. doi: 10.1046/j.1440-1681.2003.03911.x.
- Background: PubMed 17318708Ferreira WP, Bertolami MC, Santos SN, Barros MR, de Matos Barretto RB, Pontes SC Jr, Fonseca FH, Carvalho AC. One-month therapy with simvastatin restores endothelial function in hypercholesterolemic children and adolescents. Pediatr Cardiol. 2007 Jan-Feb;28(1):8-13. doi: 10.1007/s00246-005-1304-x. Epub 2007 Jan 25.
- Background: PubMed 20209376Monteiro CM, Pinheiro LF, Izar MC, Barros SW, Vasco MB, Fischer SM, Povoa RM, Brandao SA, Santos AO, Oliveira L, Carvalho AC, Fonseca FA. Highly sensitive C-reactive protein and male gender are independently related to the severity of coronary disease in patients with metabolic syndrome and an acute coronary event. Braz J Med Biol Res. 2010 Mar;43(3):297-302. doi: 10.1590/s0100-879x2010005000008. Epub 2010 Mar 5.
- Background: PubMed 21673561da Silva EF, Fonseca FA, Franca CN, Ferreira PR, Izar MC, Salomao R, Camargo LM, Tenore SB, Lewi DS. Imbalance between endothelial progenitors cells and microparticles in HIV-infected patients naive for antiretroviral therapy. AIDS. 2011 Aug 24;25(13):1595-601. doi: 10.1097/QAD.0b013e32834980f4.
- Background: PubMed 22214900Franca CN, Pinheiro LF, Izar MC, Brunialti MK, Salomao R, Bianco HT, Kasmas SH, Barbosa SP, de Nucci G, Fonseca FA. Endothelial progenitor cell mobilization and platelet microparticle release are influenced by clopidogrel plasma levels in stable coronary artery disease. Circ J. 2012;76(3):729-36. doi: 10.1253/circj.cj-11-1145. Epub 2011 Dec 28.
- Background: PubMed 15772516Pomaro DR, Ihara SS, Pinto LE, Ueda I, Casarini DE, Ebihara F, Santos AO, Izar MC, Fonseca FA. High glucose levels abolish antiatherosclerotic benefits of ACE inhibition in alloxan-induced diabetes in rabbits. J Cardiovasc Pharmacol. 2005 Apr;45(4):295-300. doi: 10.1097/01.fjc.0000155384.64350.45.
- Background: PubMed 20215709Relvas WG, Izar MC, Segreto HR, Giordani AJ, Ihara SS, Mariano M, Lopes JD, Popi AF, Helfenstein T, Pomaro D, Povoa RM, Carvalho AC, Fonseca FA. Resident peritoneal inflammatory cells are pivotal in the development of experimental atherosclerosis. J Atheroscler Thromb. 2010 Apr 30;17(4):378-85. doi: 10.5551/jat.3418. Epub 2010 Mar 9.
- Background: PubMed 21272105Helfenstein T, Fonseca FA, Ihara SS, Bottos JM, Moreira FT, Pott H Jr, Farah ME, Martins MC, Izar MC. Impaired glucose tolerance plus hyperlipidaemia induced by diet promotes retina microaneurysms in New Zealand rabbits. Int J Exp Pathol. 2011 Feb;92(1):40-9. doi: 10.1111/j.1365-2613.2010.00753.x.
- Background: PubMed 22139433Feio CA, Izar MC, Ihara SS, Kasmas SH, Martins CM, Feio MN, Maues LA, Borges NC, Moreno RA, Povoa RM, Fonseca FA. Euterpe oleracea (acai) modifies sterol metabolism and attenuates experimentally-induced atherosclerosis. J Atheroscler Thromb. 2012;19(3):237-45. doi: 10.5551/jat.11205. Epub 2011 Dec 3.
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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.
Francisco A Fonseca, MD, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin plus clopidogrel, Rosuvastatin plus ticagrelor and Simvastatin plus clopidogrel in people with Myocardial Fibrosis, run by Federal University of São Paulo at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisco A Fonseca, MD, PhD (+55 11 992639082, fahfonseca@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the left ventricular function (MRI) between the four combined treatments, after STEMI (time frame: 1-mo). 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 NCT02428374, which also lists 120 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 11 Jun 2015.