The Study of Atherosclerosis With Ramipril and Rosiglitazone

NCT ID: NCT00140647

Last Updated: 2008-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2006-07-31

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.

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.

Conditions

Atherosclerosis; Impaired Glucose Tolerance; Isolated Impaired Fasting Glucose; Cardiovascular Disease

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Ramipril

Intervention Type: DRUG

Rosiglitazone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role: collaborator

Gerstein, Hertzel, MD

INDIV

Sponsor Role: lead

Principal Investigators

Eva Lonn, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

References

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.

Reference Type: DERIVED

PMID: 19477351 (View on PubMed)

Other Identifiers

STARR

Identifier Type: -

Identifier Source: org_study_id