Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases. (PRIMARIA)
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atherosclerosis Cardiovascular Diseases |
Drug: Simvastatin or Atorvastatin Drug: Enalapril Drug: Aspirin or clopidogrel Drug: Rimonabant |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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. |
- Carotid Intima-Media Thickness progression/regression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Cardio and cerebrovascular eventS [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2948 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 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.
|
|
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 Name: Rimonabant is allowed.
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Blai Coll, MD,PhD | +34 619633249 | bcoll@arnau.scs.es |
| Spain | |
| Hospital Arnau de Vilanova | Recruiting |
| Lleida, Catalunya, Spain, 25260 | |
| Contact: Blai Coll, MD,PhD +34 619633249 bcoll@arnau.scs.es | |
| Sub-Investigator: Blai Coll, MD,PhD | |
| Sub-Investigator: Merce Borras, MD,PhD | |
| Principal Investigator: | Elvira Fernandez, MD,PhD | Hospital Arnau de Vilanova |
More Information
No publications provided
| Responsible Party: | Elvira Fernandez, Hospital Arnau de Vilanova |
| ClinicalTrials.gov Identifier: | NCT00734123 History of Changes |
| Other Study ID Numbers: | UDETMA_08, UDETMA_2008_001 |
| Study First Received: | August 11, 2008 |
| Last Updated: | August 13, 2008 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Hospital Arnau de Vilanova:
|
Atherosclerosis Cardiovascular Prevention Carotid Intima-Media Thickness Ankle-Brachial Index |
Additional relevant MeSH terms:
|
Atherosclerosis Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Aspirin Clopidogrel Enalapril Enalaprilat Simvastatin Atorvastatin Angiotensin-Converting Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013