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Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP) — EFAP  

Cardiovascular Risk Factors Clinical Trial

Official title:
Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen in Primary Prevention of Cardiovascular Disease

Clinical Trial Summary

Objectives:

- To study the possible effects of an intensive lifestyle change program on, the plasma fibrinogen levels in patients with no cardiovascular disease, with a high fibrinogen and normal cholesterol levels, and moderate Cardiovascular Risk (CVR).

- To analyse whether or not the effect on fibrinogen is independent of the effect on lipids.

Methods: Controlled, randomised clinical trial in 13 Basic Health Areas (BHA) in L'Hospitalet de Llobregat (Barcelona) and Barcelona city. Of the 436 patients between 35 and 75 years with no cardiovascular disease, with a high plasma fibrinogen (> 300 mg/dl) and a plasma cholesterol < 250 mg/dl, 218 received a more frequent and intensive intervention, consisting of advice on lifestyle changes and treatment. The follow up frequency of the intervention group was every two months. The other 218 patients continued with their usual care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01089530
Study type Interventional
Source Jordi Gol i Gurina Foundation
Contact
Status Completed
Phase N/A
Start date January 2003
Completion date December 2006
View Details
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