Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects (PPCVD)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pre-diabetes; Pre-hypertension	Drug: Metformin+Enalapril+Simvastatin; Drug: Placebo tablet	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	8900 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Primary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial
Study Start Date :	January 2012
Estimated Primary Completion Date :	July 2016
Estimated Study Completion Date :	December 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Metformin+Enalapril+Simvastatin	Drug: Metformin+Enalapril+Simvastatin; 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; Other Name: Poly-pill
Placebo Comparator: Placebo tablet	Drug: Placebo tablet; Identical Placebo Tablet; Other Name: Placebo

Outcome Measures

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Primary Outcome Measures :

1. Cardiovascular Events [ Time Frame: 4-year ]
   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)

Secondary Outcome Measures :

1. Micro-vascular Complications [ Time Frame: 4-year ]
   Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy
2. Cumulative Incidence of Diabetes [ Time Frame: 4-year ]
3. Cumulative Incidence of Hypertension [ Time Frame: 4-year ]
4. Incidence of Individual Cardiovascular Disease [ Time Frame: 4-year ]

   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

Eligibility Criteria

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Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Pre-diabetes
• Pre-hypertensives
• LDL-Cholesterol >= 100 < 190 mg/dl
• BMI >= 23
• Estimated GFR >= 60 ml/min/1.73 m2 (MDRD equation)
• Willing to participate and provide written inform consent

Exclusion Criteria:

• Current involved in other studied medications
• Regular use of corticosteroids
• Current use of weight loss medication
• History of renal disease
• Active liver disease including jaundice, chronic hepatitis with ALT >= 2.5 the upper normal limit
• Active malignancy
• Major psychiatric disorder
• Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing's syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, antipsychotics)
• Nursing women, pregnant women, or those that plan to become pregnant in the study period

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Phisitt Vejakama, M.D.	66849562882	toughcountrydoc@gmail.com
Contact: Ammarin Thakkinstian, Ph.D.	66818436266	raatk@mahidol.ac.th

Locations

Thailand
Ubon ratchathani Public Health Office	Not yet recruiting
Muang District, Ubon ratchathani, Thailand, 34000
Principal Investigator: Phisitt Vejakama, M.D.

Sponsors and Collaborators

Ramathibodi Hospital

Ubon Ratchathani Public Health Office, Thailand

National Health Security Office, Thailand

The Government Pharmaceutical Organization

Investigators

Principal Investigator:	Phisitt Vejakama, M.D.	Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Phisitt Vejakama, Section for clinical epidemiology, Faculty of medicine, Ramathibodi hospital, Thailand
ClinicalTrials.gov Identifier:	NCT01364675 History of Changes
Other Study ID Numbers:	12011
First Posted:	June 2, 2011
Last Update Posted:	June 2, 2011
Last Verified:	May 2011

Keywords provided by Ramathibodi Hospital:

Impaired fasting glucose; Impaired glucose tolerance; Pre-diabetes; Pre-hypertensives; Cardiovascular events

Additional relevant MeSH terms:

Cardiovascular Diseases; Prediabetic State; Glucose Intolerance; Prehypertension; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Vascular Diseases; Metformin; Simvastatin; Enalapril	Enalaprilat; Hypoglycemic Agents; Physiological Effects of Drugs; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors; Protease Inhibitors; Antihypertensive Agents