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The purpose of this study is to determine whether a polipill improved the compliance with treatment compared to usual care that use two or more drugs,in patients at high cardiovascular risk or previous cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polipillV1 | Experimental | poli pill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg |
|
| polipillV2 | Experimental | Polipill versão2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg. |
|
| usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polipillV1 | Drug | polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| compliance with treatment | 18 months | |
| changed in blood pressure | 18 months | |
| changes in LDL-cholesterol levels | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| the main reason for non compliance with treatment | 18 months | |
| safety of poli pill measures by laboratorial tests | hemogram and blood platelets count, liver function tests (ALT, AST), renal function tests (creatinine). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Otavio Berwanger, PhD | Instituto de Ensino e Pesquisa - IEP - HCor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Ensino e Pesquisa - IEP - HCor | São Paulo | 04005-000 | Brazil |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D017706 | Lisinopril |
| D019821 | Simvastatin |
| D001262 | Atenolol |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| polipillV2 | Drug | Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg. |
|
|
| usual care | Drug | the drugs used in clinical practice, defined by physician |
|
|
| 18 months |
| combined outcome | compound of cardiovascular and total mortality, major cardiovascular events and cholesterol levels. | 18 months |
| D008148 |
| Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |