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| ID | Type | Description | Link |
|---|---|---|---|
| UDETMA_2008_001 |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
|
| 2 | Active Comparator | Participants assigned to control group (2) will be followed according to the clinical standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin or Atorvastatin | Drug | Simvastatin 10-40 mg or Atorvastatin 20-40 mg will be prescribed according to LDL cholesterol reduction target. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carotid Intima-Media Thickness progression/regression | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cardio and cerebrovascular eventS | 5 years |
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Inclusion Criteria
One or more of the following:
The presence of two or more of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blai Coll, MD,PhD | Contact | +34 619633249 | bcoll@arnau.scs.es |
| Name | Affiliation | Role |
|---|---|---|
| Elvira Fernandez, MD,PhD | Hospital Arnau de Vilanova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Arnau de Vilanova | Recruiting | Lleida | Catalonia | 25260 | Spain |
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| Enalapril | Drug | Enalapril 10 mg/day will be prescribed as the initial treatment. Doses and adding drugs will be titrated accordingly |
|
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| Aspirin or clopidogrel | Drug | Aspirin 100 mg or clopidogrel 75 mg/ per day |
|
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| Rimonabant | Drug | 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 |
|
|
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000069059 | Atorvastatin |
| D004656 | Enalapril |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D004232 | Diuretics |
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000077285 | Rimonabant |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011720 | Pyrazoles |
| D010880 | Piperidines |
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