Rosiglitazone and Ramipril in Cardiovascular Disease and Atherosclerosis and Impaired Glucose Tolerance - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

1200

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerstein, Hertzel, MD

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator: Eva Lonn, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria