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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Ramathibodi Hospital.
Recruitment status was:  Not yet recruiting
Ubon Ratchathani Public Health Office, Thailand
National Health Security Office, Thailand
The Government Pharmaceutical Organization
Information provided by:
Ramathibodi Hospital Identifier:
First received: May 31, 2011
Last updated: June 1, 2011
Last verified: May 2011
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
Drug: Metformin+Enalapril+Simvastatin
Drug: Placebo tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • 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:
  • Micro-vascular Complications [ Time Frame: 4-year ]
    Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy

  • Cumulative Incidence of Diabetes [ Time Frame: 4-year ]
  • Cumulative Incidence of Hypertension [ Time Frame: 4-year ]
  • 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

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.

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

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 identifier: NCT01364675

Contact: Phisitt Vejakama, M.D. 66849562882
Contact: Ammarin Thakkinstian, Ph.D. 66818436266

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
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 Identifier: NCT01364675     History of Changes
Other Study ID Numbers: 12011
Study First Received: May 31, 2011
Last Updated: June 1, 2011

Keywords provided by Ramathibodi Hospital:
Impaired fasting glucose
Impaired glucose tolerance
Cardiovascular events

Additional relevant MeSH terms:
Cardiovascular Diseases
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Antihypertensive Agents processed this record on May 25, 2017