Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction

NCT02291796 | Completed Phase 4 DMC

• 1 other identifier: R-2010-3604-17
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Myocardial Infarction

Keywords

Bezafibrate; Hyperfibrinogenemia; Inflammatory response; Acute myocardial infarction; Mayor cardiovascular events

Outcome Measures

Primary Outcomes (2)

• Fibrinogen levels

  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.

  From hospital stay to 3 months

• Inflammatory response

  Concentration of cytokines (IL-8, IL-1β, IL-6, IL-10, TNF e IL-12) measured by ELISA system (Biosource)

  From hospital stay to 1 month

Secondary Outcomes (2)

• Recurrence of major cardiovascular events

  From hospital stay to 1 month

• Safety of treatment with bezafibrate (Any side effect that comes with the intake of bezafibrate)

  From hospital stay to 1 month

Study Arms (2)

Bezafibrate group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients with acute coronary syndrome with ST elevation and hyperfibrinogenemia who received only conventional anti-ischemic treatment

Interventions

Bezafibrate DRUG

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

Bezafibrate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

MeSH Terms

Interventions

Bezafibrate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzoates; Acids, Carbocyclic; Chlorobenzoates; Phenyl Ethers; Ethers; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Maria A Madrid-Miller, MD

  Head of the Division of Health Research UMAE Hospital de Cardiologia, Centro Médico Nacional Siglo XXI, IMSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Division of Health Research, UMAE Hospital de Cardiologia, Centro Médico Nacional Siglo XXI, IMSS, México, D.F.

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 14, 2014

Record last verified: 2014-11