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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified May 2011 by Ramathibodi Hospital

Sponsor:

Collaborators:

Ubon Ratchathani Public Health Office, Thailand

National Health Security Office, Thailand

The Government Pharmaceutical Organization

Information provided by:

Ramathibodi Hospital

ClinicalTrials.gov Identifier:

NCT01364675

First received: May 31, 2011

Last updated: June 1, 2011

Last verified: May 2011

History of Changes

Purpose

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	Intervention
Pre-diabetes Pre-hypertension	Drug: Metformin+Enalapril+Simvastatin Drug: Placebo tablet


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Prediabetes

Drug Information available for: Metformin Metformin hydrochloride Enalapril Enalapril maleate Enalaprilat Simvastatin

U.S. FDA Resources

Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:

Cardiovascular Events [ Time Frame: 4-year ] [ Designated as safety issue: Yes ]
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:

Micro-vascular Complications [ Time Frame: 4-year ] [ Designated as safety issue: Yes ]
Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy
Cumulative Incidence of Diabetes [ Time Frame: 4-year ] [ Designated as safety issue: Yes ]
Cumulative Incidence of Hypertension [ Time Frame: 4-year ] [ Designated as safety issue: Yes ]
Incidence of Individual Cardiovascular Disease [ Time Frame: 4-year ] [ Designated as safety issue: Yes ]
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


Estimated Enrollment:	8900
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	July 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364675

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


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
Study First Received:	May 31, 2011
Last Updated:	June 1, 2011
Health Authority:	Thailand: Ethical Committee

Keywords provided by Ramathibodi Hospital:


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

Additional relevant MeSH terms:


Prediabetic State Cardiovascular Diseases 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

ClinicalTrials.gov processed this record on September 28, 2016

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