Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases. (PRIMARIA)

Tracking Information
First Submitted Date ICMJE	August 11, 2008
First Posted Date ICMJE	August 14, 2008
Last Update Posted Date	August 14, 2008
Study Start Date ICMJE	April 2008
Estimated Primary Completion Date	April 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 13, 2008)	Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: August 13, 2008)	Cardio and cerebrovascular eventS [ Time Frame: 5 years ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.
Official Title ICMJE	Early Detection of Atherosclerosis in the Primary Care Setting: a Randomized Trial to Assess the Efficacy of a Novel Strategy in the Primary Prevention of Cardiovascular Diseases.
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.
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 Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Atherosclerosis; Cardiovascular Diseases
Intervention ICMJE	Drug: Simvastatin or Atorvastatin Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target. Other Names: Simvastatin 10-40. Atorvastatin 20-40.; Drug: Enalapril Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly Other Names: ACE inhibitors. ACE + diuretic; Drug: Aspirin or clopidogrel Aspirin 100 mg or clopidogrel 75 mg/ per day Other Name: Antiplatelets; 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 Name: Rimonabant is allowed.
Study Arms	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. Interventions: Drug: Simvastatin or Atorvastatin Drug: Enalapril Drug: Aspirin or clopidogrel Drug: Rimonabant; Active Comparator: 2 Participants assigned to control group (2) will be followed according to the clinical standard of care. Intervention: Drug: Rimonabant
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: August 13, 2008)	2948
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	May 2013
Estimated Primary Completion Date	April 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.; High blood pressure (recently diagnosed).; Abdominal perimeter: > 102 cm. males; > 88 cm. females.; 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	40 Years to 74 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Spain
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00734123
Other Study ID Numbers ICMJE	UDETMA_08; UDETMA_2008_001
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Elvira Fernandez, Hospital Arnau de Vilanova
Study Sponsor ICMJE	Hospital Arnau de Vilanova
Collaborators ICMJE	Pfizer
Investigators ICMJE	Principal Investigator: Elvira Fernandez, MD,PhD Hospital Arnau de Vilanova
PRS Account	Hospital Arnau de Vilanova
Verification Date	August 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP