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

Pre-diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01364675
• Other study ID #: 12011
• Status: Not yet recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: June 1, 2011
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: May 2011
• Source: Ramathibodi Hospital
• Contact: Phisitt Vejakama, M.D.
• Phone: 66849562882
• Email: toughcountrydoc[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8900
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Glucose Intolerance
• Pre-diabetes
• Pre-hypertension
• Prediabetic State
• Prehypertension

Intervention

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
• Placebo tablet
Identical Placebo Tablet

Locations

Country	Name	City	State
Thailand	Ubon ratchathani Public Health Office	Muang District	Ubon ratchathani

Sponsors (4)

Lead Sponsor	Collaborator
Ramathibodi Hospital	National Health Security Office, Thailand, The Government Pharmaceutical Organization, Ubon Ratchathani Public Health Office, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	4-year	Yes
Secondary	Micro-vascular Complications	Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy	4-year	Yes
Secondary	Cumulative Incidence of Diabetes		4-year	Yes
Secondary	Cumulative Incidence of Hypertension		4-year	Yes
Secondary	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	4-year	Yes