Myocardial IschaemiaPhase 3NCT00657527
Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease
A Phase 3 study testing Rosuvastatin and Cholesterol lowering diet in people with Myocardial Ischaemia and Coronary Artery Disease, run by AstraZeneca.
Trial summary
The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischaemia, Coronary Artery Disease
- What is being tested?
- Rosuvastatin and Cholesterol lowering diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Dec 2002
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of Coronary arterial disease
- Suffering ischaemic episodes/exercise induced ischaemia
- Not taking any cholesterol lowering medication
Who cannot join
- Unstable angina or heart attack less than one month before trial entry
- Coronary arterial surgery as defined by protocol
- Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.
About this study
Official title: An 8-Week Randomized Double Blind Placebo Controlled Multicenter Trial to Evaluate the Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease.
The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.
- Conditions
- Myocardial Ischaemia, Coronary Artery Disease
- Being tested
- Rosuvastatin, Cholesterol lowering diet
- Keywords
- Crestor, Rosuvastatin, Cholesterol, Coronary artery disease, Myocardial ischaemia.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Cholesterol lowering dietBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rosuvastatin Receives: Drug: Rosuvastatin |
| 2 | No intervention | Diet Receives: Behavioral: Cholesterol lowering diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.
Measured: 8 weekly
Secondary outcomes (3)
Change in duration of ischemic episodes
Measured: 8 weekly
Safety
Measured: 8 weekly
Several laboratory parameters as detailed in the protocol
Measured: 8 weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startDec 2001
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschaemiaStudies 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Cressman, DO, Study director, AstraZenecaRussell Esterline, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657527
- Sponsor's protocol ID
- 4522IL/0043
- Other IDs
- D3560C00043
- Status last verified
- Mar 2009
- First submitted
- 8 Apr 2008
- Last updated
- 16 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week Randomized Double Blind Placebo Controlled Multicenter Trial to Evaluate the Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease.
- ClinicalTrials.gov ID
- NCT00657527
- Acronym / sponsor ID
- 4522IL/0043
- Conditions
- Myocardial Ischaemia, Coronary Artery Disease
- Keywords
- Crestor, Rosuvastatin, Cholesterol, Coronary artery disease, Myocardial ischaemia.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2001
- Study completion
- Dec 2002 (actual)
- First posted
- 14 Apr 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 purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RosuvastatinRosuvastatin |
| 2 | No intervention | Behavioral: Cholesterol lowering dietDiet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Evidence of Coronary arterial disease
- Suffering ischaemic episodes/exercise induced ischaemia
- Not taking any cholesterol lowering medication
Key exclusion criteria (3 listed)
- Unstable angina or heart attack less than one month before trial entry
- Coronary arterial surgery as defined by protocol
- Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.
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: Crestor | Drug | 1 |
| Cholesterol lowering diet | Behavioural | 2 |
Primary outcome
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.
Time frame: 8 weekly
3 secondary outcomes
Change in duration of ischemic episodes
Time frame: 8 weekly
Safety
Time frame: 8 weekly
Several laboratory parameters as detailed in the protocol
Time frame: 8 weekly
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 16 Mar 2009.
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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.
Michael Cressman, DO study director
AstraZeneca
Russell Esterline study chair
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin and Cholesterol lowering diet in people with Myocardial Ischaemia and Coronary Artery Disease, run by AstraZeneca.
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 3 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 16 Mar 2009. 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?
Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring. (time frame: 8 weekly). 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 16 Mar 2009.