Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Alistair Hall


Contact details

The BHF Heart Research Centre G Floor
Jubilee Building
Leeds General Infirmary
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


New definition myocardial infarction


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

The BHF Heart Research Centre G Floor
United Kingdom

Sponsor information


University of Leeds (UK)

Sponsor details

Research Office
Room 7.11
Level 7
Worsley Building
University of Leeds
United Kingdom

Sponsor type




Funder type


Funder name

AstraZeneca (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



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
2. 2010 results of GEOSTAT-1 sub-study in

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes