AtherosclerosisEarly Phase 1NCT00783042
Exploratory Study of Coronary Flow Reserve Measurements, a Non-Invasive Method for Coronary Function Measurements
A Early Phase 1 study testing Rosuvastatin in people with Atherosclerosis and Inflammatory Activity in Coronary Arteries, run by AstraZeneca at 1 site in Sweden.
Trial summary
The aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug effects. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Atherosclerosis, Inflammatory Activity in Coronary Arteries
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to May 2009
- Phase
- Early Phase 1
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged 45-75 years or females aged 60-75 years inclusive
- Carotid and/or femoral atherosclerotic plaque, as assessed by carotid ultrasound examination within the last 5 years
- Abnormal concentrations of lipids or lipoproteins in the blood
- Provision of signed informed consent
Who cannot join
- Treatment with statins or other lipid-lowering drugs, e.g. fibrates, nicotinic acid, cholesterol absorption inhibitor, within the last 6 months before randomisation
- Current smoking or snuff tobacco use
- Major CV event (myocardial infarction (MI), stroke/ transitory ischemic attack (TIA), Acute Coronary Syndrome (ACS), revascularisation) within the last 6 months before randomisation
- Symptomatic carotid stenosis, atrioventricular (AV) block, QT-prolongation, atrial fibrillation, sinus node disease (such as sick sinus syndrome or symptomatic bradycardia), chronic obstructive pulmonary disease (COPD) or asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Transthoracic Doppler Echocardiography Method as a Non-Invasive Method for Coronary Function Measurements; Ability to Detect Short-Term Statin Effects in Patients With Increased Cardiovascular Risk
The aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug effects.
- Being tested
- Rosuvastatin, Placebo
- Keywords
- TTDE-CFR, coronary artery function, cardiovascular biomarkers, rosuvastatin, Crestor
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).
PlaceboDrug
Tablet, oral, once daily for 1 month (double blind)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Rosuvastatin |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline
Measured: Baseline and after 1 month of treatment
Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment
Measured: Baseline and after 1 month of treatment
Secondary outcomes (3)
Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month
Measured: Bseline, after 1 month and after 3 months of treatment
Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups
Measured: Baseline and after 1 month of treatment
Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups
Measured: Baseline and after 1 month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Björn Fagerberg, MD, Professor, Principal investigator, Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 GöteborgMaria Leonsson-Zachrissson, MD, Study chair, AstraZeneca R&D Mölndal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783042
- Sponsor's protocol ID
- D1840M00006
- Status last verified
- Jun 2009
- First submitted
- 30 Oct 2008
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Transthoracic Doppler Echocardiography Method as a Non-Invasive Method for Coronary Function Measurements; Ability to Detect Short-Term Statin Effects in Patients With Increased Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT00783042
- Acronym / sponsor ID
- D1840M00006
- Keywords
- TTDE-CFR, coronary artery function, cardiovascular biomarkers, rosuvastatin, Crestor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Study completion
- May 2009 (actual)
- First posted
- 31 Oct 2008 (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 aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Rosuvastatin |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males aged 45-75 years or females aged 60-75 years inclusive
- Carotid and/or femoral atherosclerotic plaque, as assessed by carotid ultrasound examination within the last 5 years
- Abnormal concentrations of lipids or lipoproteins in the blood
- Provision of signed informed consent
Key exclusion criteria (4 listed)
- Treatment with statins or other lipid-lowering drugs, e.g. fibrates, nicotinic acid, cholesterol absorption inhibitor, within the last 6 months before randomisation
- Current smoking or snuff tobacco use
- Major CV event (myocardial infarction (MI), stroke/ transitory ischemic attack (TIA), Acute Coronary Syndrome (ACS), revascularisation) within the last 6 months before randomisation
- Symptomatic carotid stenosis, atrioventricular (AV) block, QT-prolongation, atrial fibrillation, sinus node disease (such as sick sinus syndrome or symptomatic bradycardia), chronic obstructive pulmonary disease (COPD) or asthma
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 |
|---|---|---|
| RosuvastatinAlso: Crestor40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open). | Drug | 1 |
| PlaceboTablet, oral, once daily for 1 month (double blind) | Drug | 2 |
Primary outcome
Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline
Time frame: Baseline and after 1 month of treatment
Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment
Time frame: Baseline and after 1 month of treatment
3 secondary outcomes
Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month
Time frame: Bseline, after 1 month and after 3 months of treatment
Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups
Time frame: Baseline and after 1 month of treatment
Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups
Time frame: Baseline and after 1 month of treatment
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 30 Jun 2009.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
Björn Fagerberg, MD, Professor principal investigator
Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 Göteborg
Maria Leonsson-Zachrissson, MD study chair
AstraZeneca R&D Mölndal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rosuvastatin in people with Atherosclerosis and Inflammatory Activity in Coronary Arteries, run by AstraZeneca at 1 site in Sweden.
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 4 inclusion and 4 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 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline (time frame: Baseline and after 1 month of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2009.