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| Name | Class |
|---|---|
| Ubon Ratchathani Public Health Office, Thailand | OTHER_GOV |
| National Health Security Office, Thailand | OTHER |
| The Government Pharmaceutical Organization | OTHER_GOV |
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The purpose of this study is to determine whether treating pre-diabetic & pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.
The risks of CVD are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. Evidence on the effectiveness of drug interventions to lower CVD events in pre-clinical stage population has been scant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin+Enalapril+Simvastatin | Experimental |
| |
| Placebo tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin+Enalapril+Simvastatin | Drug | Poly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Events | Fatal or Non-fatal Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization, Fatal or Non-fatal Stroke, Amputation of Lower Extremities (non-traumatic cause) | 4-year |
| Measure | Description | Time Frame |
|---|---|---|
| Micro-vascular Complications | Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy | 4-year |
| Cumulative Incidence of Diabetes | 4-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phisitt Vejakama, M.D. | Contact | 66849562882 | toughcountrydoc@gmail.com | |
| Ammarin Thakkinstian, Ph.D. | Contact | 66818436266 | raatk@mahidol.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Phisitt Vejakama, M.D. | Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ubon ratchathani Public Health Office | Muang District | Changwat Ubon Ratchathani | 34000 | Thailand |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo tablet | Drug | Identical Placebo Tablet |
|
|
| Cumulative Incidence of Hypertension | 4-year |
| Incidence of Individual Cardiovascular Disease | Coronary Artery Disease - Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization Stroke- Cerebral Hemorrhage, Cerebral Infarction, Subarachnoid Hemorrhage Peripheral Artery Disease- Leg amputation, endovascular or surgical intervention in leg arteries | 4-year |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |