Role of Immune Responses After Acute Myocardial Infarction

NCT ID: NCT02428374

Last Updated: 2015-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-07-31

Brief 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. 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.

Conditions

Myocardial Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

rosuvastatin plus clopidogrel

rosuvastatin 40 mg and clopidogrel 75 mg

Group Type: ACTIVE_COMPARATOR

Rosuvastatin plus ticagrelor

Intervention Type: DRUG

Crestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Simvastatin plus clopidogrel

Intervention Type: DRUG

Zocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo

Simvastatin plus ticagrelor

Intervention Type: DRUG

Zocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Rosuvastatin plus ticagrelor

Rosuvastatin 40 mg plus ticagrelor 90 mg bid

Group Type: ACTIVE_COMPARATOR

Rosuvastatin plus clopidogrel

Intervention Type: DRUG

Crestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo

Simvastatin plus clopidogrel

Intervention Type: DRUG

Zocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo

Simvastatin plus ticagrelor

Intervention Type: DRUG

Zocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

simvastatin plus clopidogrel

Simvastatin 40 mg plus clopidogrel 75 mg

Group Type: ACTIVE_COMPARATOR

Rosuvastatin plus clopidogrel

Intervention Type: DRUG

Crestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo

Rosuvastatin plus ticagrelor

Intervention Type: DRUG

Crestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Simvastatin plus ticagrelor

Intervention Type: DRUG

Zocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Simvastatin plus ticagrelor

Simvastatin 40 mg plus ticagrelor 90 mg bid

Group Type: ACTIVE_COMPARATOR

Rosuvastatin plus clopidogrel

Intervention Type: DRUG

Crestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo

Rosuvastatin plus ticagrelor

Intervention Type: DRUG

Crestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Simvastatin plus clopidogrel

Intervention Type: DRUG

Zocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo

Interventions

Rosuvastatin plus clopidogrel

Crestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo

Intervention Type: DRUG

Rosuvastatin plus ticagrelor

Crestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Intervention Type: DRUG

Simvastatin plus clopidogrel

Zocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo

Intervention Type: DRUG

Simvastatin plus ticagrelor

Zocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo

Intervention Type: DRUG

Other Intervention Names

Crestor & Plavix; Crestor & Brilinta; Zocor plus Plavix; Zocor & Brilinta

Eligibility Criteria

Inclusion Criteria

1. Stable patients with ST elevation myocardial infarction (STEMI) treated with thrombolytics in the first 6h or the initial of symptoms of MI.

Exclusion Criteria

1. Contraindication or known intolerance to the study drug protocol

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Francisco Antonio Helfenstein Fonseca

Affiliate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco A Fonseca, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Hospital Sao Paulo - UNIFESP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Francisco A Fonseca, MD, PhD

Role: CONTACT

fahfonseca@terra.com.br

+55 11 992639082

Maria C Izar, MD, PhD

Role: CONTACT

mcoizar@terra.com.br

+55 11

Facility Contacts

Francisco A H Fonseca, MD, PhD

Role: primary

fahfonseca@terra.com.br

+5511992639082

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Other Identifiers

FAPESP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EPM/UNIFESP

Identifier Type: -

Identifier Source: org_study_id