The Study of Atherosclerosis With Ramipril and Rosiglitazone

• ClinicalTrials.gov Identifier: NCT00140647
• Recruitment Status: Completed
• First Posted: September 1, 2005
• Last Update Posted: August 25, 2008
• Sponsor: Gerstein, Hertzel, MD
• Collaborator: Heart and Stroke Foundation of Ontario
• Information provided by: Gerstein, Hertzel, MD

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Atherosclerosis; Impaired Glucose Tolerance; Isolated Impaired Fasting Glucose; Cardiovascular Disease	Drug: Ramipril; Drug: Rosiglitazone	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: The Study of Atherosclerosis With Ramipril and Rosiglitazone
• Study Start Date: July 2001
• Actual Study Completion Date: July 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Gerstein, Hertzel, MD

Heart and Stroke Foundation of Ontario

Investigators

• Principal Investigator: Eva Lonn, MD; McMaster University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lonn EM, Gerstein HC, Sheridan P, Smith S, Diaz R, Mohan V, Bosch J, Yusuf S, Dagenais GR; DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) and STARR Investigators. Effect of ramipril and of rosiglitazone on carotid intima-media thickness in people with impaired glucose tolerance or impaired fasting glucose: STARR (STudy of Atherosclerosis with Ramipril and Rosiglitazone). J Am Coll Cardiol. 2009 Jun 2;53(22):2028-35. doi: 10.1016/j.jacc.2008.12.072.

• ClinicalTrials.gov Identifier: NCT00140647
• Other Study ID Numbers: STARR
• First Posted: September 1, 2005
• Last Update Posted: August 25, 2008
• Last Verified: August 2008

Keywords provided by Gerstein, Hertzel, MD:

atherosclerosis; carotid artery; ramipril; rosiglitazone; impaired glucose tolerance; impaired fasting glucose; diabetes prevention

Additional relevant MeSH terms:

Cardiovascular Diseases; Atherosclerosis; Glucose Intolerance; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Rosiglitazone; Ramipril; Hypoglycemic Agents; Physiological Effects of Drugs; Angiotensin-Converting Enzyme Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents