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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
Recruitment status was: Not yet recruiting
Sponsor:
Ramathibodi Hospital
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
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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 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 |
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.
Eligibility| 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
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
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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017