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

Overview[ - collapse ][ - ]

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.
ConditionPre-diabetes
Pre-hypertension
InterventionDrug: Metformin+Enalapril+Simvastatin
Drug: Placebo tablet
PhaseN/A
SponsorRamathibodi Hospital
Responsible PartyRamathibodi Hospital
ClinicalTrials.gov IdentifierNCT01364675
First ReceivedMay 31, 2011
Last UpdatedJune 1, 2011
Last verifiedMay 2011

Tracking Information[ + expand ][ + ]

First Received DateMay 31, 2011
Last Updated DateJune 1, 2011
Start DateJanuary 2012
Estimated Primary Completion DateDecember 2016
Current Primary Outcome MeasuresCardiovascular 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)
Current 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

Descriptive Information[ + expand ][ + ]

Brief TitlePrimary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects
Official TitlePrimary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial
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.
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 TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Condition
  • Pre-diabetes
  • Pre-hypertension
InterventionDrug: 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 Names:
Poly-pillDrug: Placebo tablet
Identical Placebo Tablet
Other Names:
Placebo
Study Arm (s)
  • Experimental: Metformin+Enalapril+Simvastatin
  • Placebo Comparator: Placebo tablet

Recruitment Information[ + expand ][ + ]

Recruitment StatusNot yet recruiting
Estimated Enrollment8900
Estimated Completion DateDecember 2016
Estimated Primary Completion DateJuly 2016
Eligibility 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
GenderBoth
Ages50 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: Phisitt Vejakama, M.D.
66849562882
toughcountrydoc@gmail.com
Location CountriesThailand

Administrative Information[ + expand ][ + ]

NCT Number NCT01364675
Other Study ID Numbers12011
Has Data Monitoring CommitteeYes
Information Provided ByRamathibodi Hospital
Study SponsorRamathibodi Hospital
CollaboratorsUbon 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
Verification DateMay 2011

Locations[ + expand ][ + ]

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