The Study of Atherosclerosis With Ramipril and Rosiglitazone

NCT00140647 | Completed Phase 3

• 1 other identifier: STARR
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

Ramipril DRUG

Rosiglitazone DRUG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gerstein, Hertzel, MD: lead
• Heart and Stroke Foundation of Ontario: collaborator

Related Publications (1)

• 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.

  PMID: 19477351 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Glucose Intolerance; Cardiovascular Diseases

Interventions

Ramipril; Rosiglitazone

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Eva Lonn, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: August 30, 2005
• First Posted: September 1, 2005
• Study Start: July 1, 2001
• Study Completion: July 1, 2006
• Last Updated: August 25, 2008

Record last verified: 2008-08