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

Primary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01364675

Acronym

PPCVD

Enrollment

8900

Registered

2011-06-02

Start date

2012-01-31

Completion date

2016-12-31

Last updated

2011-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes, Pre-hypertension

Keywords

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

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.

Interventions

DRUGMetformin+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

DRUGPlacebo tablet

Identical Placebo Tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiovascular Events	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

Measure	Time frame	Description
Micro-vascular Complications	4-year	Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy
Cumulative Incidence of Diabetes	4-year	—
Cumulative Incidence of Hypertension	4-year	—
Incidence of Individual Cardiovascular Disease	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

Countries

Thailand

Contacts

Primary ContactPhisitt Vejakama, M.D.

toughcountrydoc@gmail.com66849562882

Backup ContactAmmarin Thakkinstian, Ph.D.

raatk@mahidol.ac.th66818436266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026