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

Primary Purpose

Pre-diabetes, Pre-hypertension

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Metformin+Enalapril+Simvastatin

Placebo tablet

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring Impaired fasting glucose, Impaired glucose tolerance, Pre-diabetes, Pre-hypertensives, Cardiovascular events

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ubon ratchathani Public Health Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin+Enalapril+Simvastatin

Placebo tablet

Arm Description

Outcomes

Primary Outcome Measures

Cardiovascular Events

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

Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy

Cumulative Incidence of Diabetes

Cumulative Incidence of Hypertension

Incidence of Individual Cardiovascular Disease

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

Full Information

NCT ID

NCT01364675

First Posted

May 31, 2011

Last Updated

June 1, 2011

Sponsor

Ramathibodi Hospital

Collaborators

Ubon Ratchathani Public Health Office, Thailand, National Health Security Office, Thailand, The Government Pharmaceutical Organization

1. Study Identification

Unique Protocol Identification Number

NCT01364675

Brief Title

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

Acronym

PPCVD

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ramathibodi Hospital

Collaborators

Ubon Ratchathani Public Health Office, Thailand, National Health Security Office, Thailand, The Government Pharmaceutical Organization

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes, Pre-hypertension

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin+Enalapril+Simvastatin

Arm Type

Experimental

Arm Title

Placebo tablet

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Metformin+Enalapril+Simvastatin

Other Intervention Name(s)

Poly-pill

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Other Intervention Name(s)

Placebo

Intervention Description

Identical Placebo Tablet

Primary Outcome Measure Information:

Title

Cardiovascular Events

Description

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)

Time Frame

4-year

Secondary Outcome Measure Information:

Title

Micro-vascular Complications

Description

Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy

Time Frame

4-year

Title

Cumulative Incidence of Diabetes

Time Frame

4-year

Title

Cumulative Incidence of Hypertension

Time Frame

4-year

Title

Incidence of Individual Cardiovascular Disease

Description

Time Frame

4-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Phisitt Vejakama, M.D.

Phone

66849562882

toughcountrydoc@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ammarin Thakkinstian, Ph.D.

Phone

66818436266

raatk@mahidol.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phisitt Vejakama, M.D.

Organizational Affiliation

Section for clinical epidemiology and bioststistics, Faculty of medicine, Ramathibodi hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ubon ratchathani Public Health Office

City

Muang District

State/Province

Ubon ratchathani

ZIP/Postal Code

34000

Country

Thailand

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Phisitt Vejakama, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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