Secondary Prevention of Acute Coronary Events. Reduction Of Cholesterol to Key European Targets: an open-label comparative investigation of efficacy, tolerance and health in 2,072 patients randomised to rosuvastatin or 'standard' simvastatin therapy following hospital admission for new definition myocardial infarction
| ISRCTN | ISRCTN89508434 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89508434 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/02/2005
- Registration date
- 03/06/2005
- Last edited
- 08/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Alistair Hall
Scientific
Scientific
The BHF Heart Research Centre G Floor
Jubilee Building
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study acronym | SPACE ROCKET |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2005 |
| Completion date | 30/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2072 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The BHF Heart Research Centre G Floor
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
Research Office
Room 7.11
Level 7
Worsley Building
University of Leeds
Leeds
LS2 9NL
England
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
Industry
AstraZeneca (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2009 | Yes | No | |
| Results article | results of GEOSTAT-1 sub-study | 01/06/2010 | Yes | No |
