Bezafibrate for Hyperfibrinogenemia in Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Mexicano del Seguro Social
• Treatments: Bezafibrate

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