Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SPACE ROCKET
Study hypothesis
The aim of the SPACE ROCKET trial is to compare the clinical effectiveness of rosuvastatin 10 mg with simvastatin 40 mg on the surrogate endpoints of cholesterol lowering and tolerance, together with their ability to achieve key European cholesterol targets, in patients admitted to hospital for new definition myocardial infarction. The trial has been designed as an open-label, multi-centre, randomised, controlled, parallel group trial with equal randomisation of 2,072 patients. Consenting patients admitted to hospital for new definition myocardial infarction will be allocated to receive either rosuvastatin 10 mg or 'standard' treatment with simvastatin 40 mg for three months.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
New definition myocardial infarction
Intervention
Patients will be randomised to receive either:
1. Simvastatin 40 mg, OR
2. Rosuvastatin 10 mg
Please note that the anticipated end date of this trial was extended to the 31st March 2007 following an extension to the funding.
Intervention type
Drug
Phase
Not Specified
Drug names
Rosuvastatin, simvastatin
Primary outcome measure
Achievement of European lipid targets (Low-Density Lipoprotein [LDL] cholesterol less than 2.5 mmol/l or Total Cholesterol [TC] less than 4.5 mmol/l) at three months.
Secondary outcome measures
1. Patient tolerance:
1.1. Withdrawal from therapy at three months
1.2. Self-reported side-effects at three months
2. Efficacy:
2.1. Comparison of lipid parameters: TC, LDL cholesterol, High-Density Lipoprotein (HDL) cholesterol and triglycerides at three months
2.2. Achievement of National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III (LDL cholesterol less than 100 mg/dl or 2.6 mmol/l) at three months
2.3. Achievement of National Service Framework (NSF) targets (LDL cholesterol less than 3.0 mmol/l or TC less than 5.0 mmol/l) at three months
2.4. Achievement of new UK Joint Society targets (LDL cholesterol less than 2.0 mmol/l or TC less than 4.0 mmol/l) at three months
3. Safety:
3.1. Serious Adverse Events (up to and including three-month follow-up)
3.2. Biochemical markers: Creatine Linase (CK), Alanine aminotransferase (ALT), creatinine and proteinuria
4. Tertiary endpoints:
4.1. Cardiovascular events
4.2. Total mortality as monitored at three months
4.3. Total mortality as monitored indefinitely via Office of National Statistics (extending beyond three-month trial follow-up)
Overall trial start date
01/04/2005
Overall trial end date
30/04/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with the following characteristics are eligible for this trial:
1. Within two weeks of new definition Myocardial Infarction (MI) defined as a typical rise of biochemical markers of myocardial necrosis with one or more of the following:
1.1. ischaemic symptoms
1.2. development of pathological Q waves on the Electrocardiogram (ECG)
1.3. ECG changes indicative of ischaemia (ST segment elevation or depression)
1.4. coronary artery intervention (e.g. primary coronary angioplasty)
2. Requiring secondary prevention with a statin in the opinion of the attending clinician
3. Patient must have given written informed consent prior to any trial-specific procedures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2072
Participant exclusion criteria
Patients with the following characteristics are ineligible for this trial, at the discretion of the attending medical team:
1. Not suitable for statin therapy as determined by the attending clinician
2. Previous statin intolerance
3. Known contra-indication for statin use:
3.1. hypersensitivity to the product
3.2. active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding three times the Upper Limit of Normal (ULN)
3.3. severe renal impairment
3.4. myopathy
3.5. concomitant cyclosporin
3.6. existing polymyositis or dermatomyositis
3.7. pre-disposing factors for myopathy/rhabdomyolysis, which include: moderate renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, alcohol abuse, situations where an increase in plasma levels may occur, concomitant use of fibrates
4. Already receiving simvastatin 80 mg or atorvastatin 80 mg at time of admission
5. Randomised to the trial during previous admission
6. Aged under 18 years at the time of recruitment
7. Women of childbearing potential not using an effective method of contraception
8. Women who are pregnant or breast-feeding
9. Participation in another pharmacotherapeutic study within the prior 30 days or currently receiving an experimental pharmacological agent
10. Taking drugs associated with rhabdomyolysis in combination with statins (i.e. strong cytochrome P450-3A4 inhibitors such as erythromycin) or other concomitant drugs with special warnings or precautions (as per Summary of Product Characteristics [SPC] for both drugs), for example: fibrates, gemfibrozil, cyclosporin, nicotinic acid, azole antifungals, protease inhibitors, macrolide antibiotics, amiodarone, verapamil, diltiazem or nefazodone
11. Proteinuria ++/+++
12. Excess alcohol consumption (greater than 50 units per week)
Recruitment start date
01/04/2005
Recruitment end date
30/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The BHF Heart Research Centre G Floor
Leeds
LS1 3EX
United Kingdom
Funders
Funder type
Industry
Funder name
AstraZeneca (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19745745
2. 2010 results of GEOSTAT-1 sub-study in http://www.ncbi.nlm.nih.gov/pubmed/20207952
Publication citations
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Results
Hall AS, Jackson BM, Farrin AJ, Efthymiou M, Barth JH, Copeland J, Bailey KM, Romaine SP, Balmforth AJ, McCormack T, Whitehead A, Flather MD, Nixon J, , A randomized, controlled trial of simvastatin versus rosuvastatin in patients with acute myocardial infarction: the Secondary Prevention of Acute Coronary Events--Reduction of Cholesterol to Key European Targets Trial., Eur J Cardiovasc Prev Rehabil, 2009, 16, 6, 712-721, doi: 10.1097/HJR.0b013e3283316ce8.
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Bailey KM, Romaine SP, Jackson BM, Farrin AJ, Efthymiou M, Barth JH, Copeland J, McCormack T, Whitehead A, Flather MD, Samani NJ, Nixon J, Hall AS, Balmforth AJ, , Hepatic metabolism and transporter gene variants enhance response to rosuvastatin in patients with acute myocardial infarction: the GEOSTAT-1 Study., Circ Cardiovasc Genet, 2010, 3, 3, 276-285, doi: 10.1161/CIRCGENETICS.109.898502.