AtherosclerosisPhase 3NCT00140647
The Study of Atherosclerosis With Ramipril and Rosiglitazone
A Phase 3 study testing Ramipril and Rosiglitazone in people with Atherosclerosis and Impaired Glucose Tolerance, run by Gerstein, Hertzel, MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Impaired Glucose Tolerance, Isolated Impaired Fasting Glucose
- What is being tested?
- Ramipril and Rosiglitazone
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Jul 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
About this study
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.
Read the 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
- Being tested
- Ramipril, Rosiglitazone
- Keywords
- atherosclerosis, carotid artery, ramipril, rosiglitazone, impaired glucose tolerance, impaired fasting glucose, diabetes prevention
- Medical subject headings
- Atherosclerosis, Glucose Intolerance, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
RosiglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startJul 2001
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 1,200 participants
Sponsor and investigators
- Lead sponsor
- Gerstein, Hertzel, MD
- Collaborators
- Heart and Stroke Foundation of Ontario
- Investigators
- Eva Lonn, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140647
- Sponsor's protocol ID
- STARR
- Status last verified
- Aug 2008
- First submitted
- 30 Aug 2005
- Last updated
- 25 Aug 2008
- Results posted
- No
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.
PubMed 19477351
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Atherosclerosis With Ramipril and Rosiglitazone
- ClinicalTrials.gov ID
- NCT00140647
- Acronym / sponsor ID
- STARR
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants
- Lead sponsor
- Gerstein, Hertzel, MD
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jul 2001
- Study completion
- Jul 2006 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramipril | Drug | – |
| Rosiglitazone | Drug | – |
Primary outcome
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.
1 secondary outcome
The change over time in the mean IMT across the common carotid far wall IMT of the right and the left carotid arteries.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2008.
- Derived from this study: PubMed 19477351Lonn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Lonn, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramipril and Rosiglitazone in people with Atherosclerosis and Impaired Glucose Tolerance, run by Gerstein, Hertzel, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00140647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2008.