Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP) (EFAP)
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|ClinicalTrials.gov Identifier: NCT01089530|
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : March 18, 2010
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Risk Factors||Behavioral: Lifestyle intensive group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||436 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen in Primary Prevention of Cardiovascular Disease|
|Study Start Date :||January 2003|
|Study Completion Date :||December 2006|
|No Intervention: Standard care||
Behavioral: Lifestyle intensive group
hipocaloric diet smoking cessation physical exercise
- To evaluate the effect of an intensive intervention to modify lifestyle (hypocaloric diet, smoking cessation and physical exercise) in the fibrinogen levels. [ Time Frame: 24 months ]
- To assess the effect of this intensive intervention in some modifiable cardiovascular risk factors. [ Time Frame: 24 months ]
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): NCT01089530
|ABS Florida Sud|
|L'Hospitalet del Llobregat, Barcelona, Spain, 08905|