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PRIMARIA: Early Detection of Atherosclerosis in Primary Care
NCT00734123Phase 4
Key facts
- Status
- Unknown
- Start
- Apr 2008
- Primary completion
- Apr 2009
- Countries
- 1
- Sponsor
- Hospital Universitari Arnau de Vilanova
- Modality
- Orthosteric Ligands
- Conditions
- atherosclerosiscardiovascular diseases (CVD)
01
Overview
Phase 4, randomised, open-label trial of simvastatin, atorvastatin, enalapril, aspirin and clopidogrel in atherosclerosis and cardiovascular diseases (CVD) (2 arms), sponsored by Hospital Universitari Arnau de Vilanova. Primary endpoint: Carotid Intima-Media Thickness progression/regression at 2 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Intensive Arm
Targeted therapeutic aims (lipids, BP, antiplatelets) based on ultrasound/ABI results using Simvastatin/Atorvastatin, Enalapril, Aspirin/Clopidogrel.
Control Group
Standard clinical care.
03
Who it enrols
Adults aged 40-74 with intermediate cardiovascular risk defined by family history, diabetes, hypertension, CKD, or hyperlipidemia, plus other risk factors like smoking or obesity. Patients with previous cardiovascular events are excluded.
04
Endpoints
Primary
Carotid Intima-Media Thickness progression/regression
Secondary
Cardio and cerebrovascular events
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