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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01089530

Acronym

EFAP

Enrollment

436

Registered

2010-03-18

Start date

2003-01-31

Completion date

2006-12-31

Last updated

2010-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factors

Keywords

Fibrinogen, Cholesterol, Cardiovascular risk factors, Primary prevention, High levels fibrinogen, High plasma fibrinogen

Brief 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.

Interventions

BEHAVIORALLifestyle intensive group

hipocaloric diet smoking cessation physical exercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients aged between 30 and 75 years, than in 2 analytical consecutive, separated by a minimum interval of 15 days, have fibrinogen plasma \> 300 mg/dl and plasma Total cholesterol \< 250 mg/dl. * Acceptance through informed consent of the patient to participate in the study.

Exclusion criteria

* Patients receiving lipid lowering treatment (including dietary measures) * Local or generalized, acute or chronic infection. * Patients with a history of cardiovascular disease.

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of an intensive intervention to modify lifestyle (hypocaloric diet, smoking cessation and physical exercise) in the fibrinogen levels.	24 months

Secondary

Measure	Time frame
To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors.	24 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026