The Study of Atherosclerosis With Ramipril and Rosiglitazone - Full Text View

Sponsors and Collaborators:	Gerstein, Hertzel, MD Heart and Stroke Foundation of Ontario
Information provided by:	Gerstein, Hertzel, MD
ClinicalTrials.gov Identifier:	NCT00140647

Purpose

The purpose of this study is to determine if ramipril and/or rosiglitazone retard the progression of atherosclerosis as evaluated by serial carotid intermedial thickness measurements.

Condition	Intervention	Phase
Atherosclerosis Impaired Glucose Tolerance Isolated Impaired Fasting Glucose Cardiovascular Disease	Drug: Ramipril Drug: Rosiglitazone	Phase III

Drug Information available for: Rosiglitazone Rosiglitazone Maleate Dextrose Ramipril

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	The Study of Atherosclerosis With Ramipril and Rosiglitazone

Further study details as provided by Gerstein, Hertzel, MD:

Primary Outcome Measures:

The change of the mean maximum carotid intimal medial thickness (IMT)evaluated across 12 segments involving the left and right common carotid, bifurcation and internal carotid arteries.

Secondary Outcome Measures:

The change over time in the mean IMT across the common carotid far wall IMT of the right and the left carotid arteries.

Estimated Enrollment:	1200
Study Start Date:	July 2001
Study Completion Date:	July 2006

Detailed Description:

STARR is a multi-centre, international, randomized controlled clinical trial with a 2x2 factorial design, that will evaluate the effects of ramipril and of rosiglitazone on atherosclerosis progression, as determined by B-mode carotid ultrasound (US). It is designed as a substudy of DREAM (Diabetes Reduction Assessment with ramipril and rosiglitazone Medications) Trial. The study is designed to enroll 1,200 study participants and follow is proposed for an average of 3.75 years.

SIGNIFICANCE OF THE PROPOSED RESEARCH: With regards to ramipril this study will provide important mechanistic data regarding potential benefits of ACE inhibitor therapy on atherosclerosis and by inference in reducing CV risk in a lower risk younger population than studied in previous trials. In this population a clinical outcome trial focusing primarily on CV events would be difficult to conduct due to the expected fairly low event rate. If the study on atherosclerosis is positive, this may provide a rational for therapy in this subset of patients without overt CVD or diabetes, but with impaired glucose tolerance or impaired fasting glucose.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

impaired glucose tolerance (FPG < 7 mmol/L or 126 mg/dL & 2hr PG between 7.8-11.0 mmol/l [140-199 mg/dl] after a 75 g OGTT
impaired glucose tolerance (FPG≥ 6.1 mmol/l [110 mg/dl]) and no diabetes (i.e. a FPG < 7.0 mmol/l [126 mg/dl])
a technically adequate baseline carotid ultrasound examination

Exclusion Criteria:

current use of an ACE-inhibitor (ACE-I) or thiazolidinedione (TZD)
known hypersensitivity to ACE-I
prior use of anti-diabetic medications 9with the exception of during pregnancy)
use of systemic glucocorticoids or niacin
congestive heart failure or EF < 40%
existing cardiovascular disease (previous MI, stroke, angina, uncontrolled hypertension)
diabetes
renal or hepatic disease
major illness
use of another experimental drug
pregnant or unwilling to use reliable contraception
major psychiatric disorder
diseases that affect glucose tolerance
unwillingness to be randomized or sign informed consent
known uncontrolled substance abuse
inability to communicate with research staff

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140647

Sponsors and Collaborators

Gerstein, Hertzel, MD

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator:

Eva Lonn, MD

McMaster University

More Information

Study ID Numbers:	STARR
Study First Received:	August 30, 2005
Last Updated:	August 21, 2008
ClinicalTrials.gov Identifier:	NCT00140647
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gerstein, Hertzel, MD:

atherosclerosis
carotid artery
ramipril
rosiglitazone

impaired glucose tolerance
impaired fasting glucose
diabetes prevention

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Metabolic Diseases
Hyperglycemia
Glucose Intolerance
Vascular Diseases

Diabetes Mellitus
Arteriosclerosis
Metabolic disorder
Glucose Metabolism Disorders
Rosiglitazone
Ramipril

Additional relevant MeSH terms:

Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009