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Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction (BEZAFIBRAMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291796
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Maria Alejandra Madrid Miller, Instituto Mexicano del Seguro Social

Brief Summary:

Introduction: Plasma fibrinogen levels have been identified as an important risk factor for cardiovascular diseases and could have a prognostic value. Bezafibrate decreases fibrinogen levels and also the incidence of major cardiovascular events in primary prevention, but its effects in acute coronary syndrome is unknown.

Hypothesis: Bezafibrate effect over statin therapy reduces fibrinogen concentrations, inflammatory response and clinical events, in patients with ST segment elevation ACS and hyperfibrinogenemia.

Methods: In a randomized clinical trial, controlled with conventional therapy. Patients with ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500 mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day (group I n=50) or just conventional therapy (group II n=50). Serum fibrinogen, c reactive protein and cytokines were measured. Clinical end points were recurrence of angina or infarction, left ventricular failure, cardiovascular mortality and combined end points during hospitalization.


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Bezafibrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Early Effect Of Bezafibrate On Fibrinogen Levels, Inflammatory Response And Clinical Impact, In Patients With ST Elevation Acute Myocardial Infarction
Study Start Date : January 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Bezafibrate group
Patients with acute coronary syndrome with ST elevation and fibrinogen receiving a dose of 400 mg every 24 hours of Bezafibrate in addition to conventional anti-ischemic treatment
Drug: Bezafibrate
Patients with ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500 mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day or just conventional therapy

No Intervention: Control group
Patients with acute coronary syndrome with ST elevation and hyperfibrinogenemia who received only conventional anti-ischemic treatment



Primary Outcome Measures :
  1. Fibrinogen levels [ Time Frame: From hospital stay to 3 months ]
    PT-Fibrinogen HS Plus kit (Beckman Coulter, Brea, CA) to determine prothrombin time and fibrinogen and to evaluate extrinsic pathway of coagulation in citrated human plasma using an auto-analyzer ACL-800 (Cobas, Roche Diagnostics, Indianapolis, IN) where fibrinogen levels are determined through turbidimetry.

  2. Inflammatory response [ Time Frame: From hospital stay to 1 month ]
    Concentration of cytokines (IL-8, IL-1β, IL-6, IL-10, TNF e IL-12) measured by ELISA system (Biosource)


Secondary Outcome Measures :
  1. Recurrence of major cardiovascular events [ Time Frame: From hospital stay to 1 month ]
    angina, reinfarction, heart failure, death, and combined endpoints

  2. Safety of treatment with bezafibrate (Any side effect that comes with the intake of bezafibrate) [ Time Frame: From hospital stay to 1 month ]
    Any side effect that comes with the intake of bezafibrate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >18 years of age who were admitted to the Cardiovascular Intensive Care Unit of the Cardiology Hospital, National Medical Center, Century XXI (Mexico City) and diagnosed with ST segment elevation ACS and hyperfibrinogenemia within 72 h of symptom onset

Exclusion Criteria:

  • Patients with known bezafibrate allergy,
  • previous fibrate treatments,
  • patients with cardiogenic shock,
  • hepatic failure,
  • renal failure,
  • history of neoplastic disease,
  • chronic inflammatory disease or active infectious process,
  • anti-inflammatory or immunosuppressive therapies,
  • fibrinolysis with streptokinase and
  • patients with triglyceride concentrations >150 mg/dl

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291796


Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: Maria A Madrid-Miller, MD Head of the Division of Health Research UMAE Hospital de Cardiologia, Centro Médico Nacional Siglo XXI, IMSS
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Responsible Party: Maria Alejandra Madrid Miller, Head of the Division of Health Research, UMAE Hospital de Cardiologia, Centro Médico Nacional Siglo XXI, IMSS, México, D.F., Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT02291796    
Other Study ID Numbers: R-2010-3604-17
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Maria Alejandra Madrid Miller, Instituto Mexicano del Seguro Social:
Bezafibrate
Hyperfibrinogenemia
Inflammatory response
Acute myocardial infarction
Mayor cardiovascular events
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Bezafibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents