The Study of Atherosclerosis With Ramipril and Rosiglitazone

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Gerstein, Hertzel, MD
ClinicalTrials.gov Identifier:
NCT00140647
First received: August 30, 2005
Last updated: August 21, 2008
Last verified: August 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Study of Atherosclerosis With Ramipril and Rosiglitazone

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Gerstein, Hertzel, MD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00140647     History of Changes
Other Study ID Numbers: STARR
Study First Received: August 30, 2005
Last Updated: August 21, 2008
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

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Glucose Intolerance
Prediabetic State
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Ramipril
Rosiglitazone
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014