Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction (BEZAFIBRAMI)
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|ClinicalTrials.gov Identifier: NCT02291796|
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
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
- 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.
- 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)
- Recurrence of major cardiovascular events [ Time Frame: From hospital stay to 1 month ]angina, reinfarction, heart failure, death, and combined endpoints
- 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
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
|Principal Investigator:||Maria A Madrid-Miller, MD||Head of the Division of Health Research UMAE Hospital de Cardiologia, Centro Médico Nacional Siglo XXI, IMSS|