PRIMARIA: Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
Study Details
Study Description
Brief Summary
The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
We will perform non-invasive techniques (carotid Intima-Media Thickness, CAC score and ankle-brachial index) to individuals at intermediate cardiovascular risk.With these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. The end-point will be the course of atherosclerosis measured by cIMT/CAC score (2 years) and the incidence of CVD at 5 years of follow-up.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Participants assigned to the intensive arm (1) will be targeted to specified therapeutic aims (concerning lipids, blood pressure and antiplatelets)according to the results of carotid ultrasound and ankle-brachial index. |
Drug: Simvastatin or Atorvastatin
Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target.
Other Names:
Drug: Enalapril
Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly
Other Names:
Drug: Aspirin or clopidogrel
Aspirin 100 mg or clopidogrel 75 mg/ per day
Other Names:
Drug: Rimonabant
In both arms, we will follow the standard clinical care in terms of treatments, as far as obesity and diabetes mellitus is concerned.
Drugs will be prescribed as the standard clinical care
Other Names:
|
| Active Comparator: 2 Participants assigned to control group (2) will be followed according to the clinical standard of care. |
Drug: Rimonabant
In both arms, we will follow the standard clinical care in terms of treatments, as far as obesity and diabetes mellitus is concerned.
Drugs will be prescribed as the standard clinical care
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Carotid Intima-Media Thickness progression/regression [2 years]
Secondary Outcome Measures
- Cardio and cerebrovascular eventS [5 years]
Eligibility Criteria
Criteria
Inclusion Criteria
One or more of the following:
-
Familiar History of early-onset cardiovascular disease (male < 55 or female < 65).
-
Type 2 Diabetes mellitus or type 1 with microalbuminuria.
-
Essential High Blood Pressure.
-
Chronic Kidney Disease.
-
Primary hyperlipidemia.
The presence of two or more of the following:
-
Current smoker.
-
Physical inactivity.
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High blood pressure (recently diagnosed).
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Abdominal perimeter: > 102 cm. males; > 88 cm. females.
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Total cholesterol > 240 mg/dL.
-
HDL cholesterol ≤ 40 mg/dL males, ≤ 50 mg/dL females.
Exclusion Criteria:
-
Age < 40 or > 74 years old.
-
Previous Cardiovascular Event.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Arnau de Vilanova | Lleida | Catalunya | Spain | 25260 |
Sponsors and Collaborators
- Hospital Arnau de Vilanova
- Pfizer
Investigators
- Principal Investigator: Elvira Fernandez, MD,PhD, Hospital Arnau de Vilanova
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UDETMA_08
- UDETMA_2008_001