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

This study is not yet open for participant recruitment.
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:

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
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
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

No publications provided

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

ClinicalTrials.gov processed this record on May 22, 2013