Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125593
Status:
COMPLETED
Last Update Posted:
2012-02-01
First Post:
2005-07-29
Brief Title:
Study of Heart and Renal Protection
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
Study of Heart and Renal Protection SHARP The Effects of Lowering LDL-cholesterol With Simvastatin 20mg Plus Ezetimibe 10mg in Patients With Chronic Kidney Disease a Randomized Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHARP
Brief Summary:
The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with simvastatin 20mg plus ezetimibe 10mg daily could safely reduce the risk of coronary heart disease non-hemorrhagic stroke and the need for revascularization procedures in patients with chronic kidney disease CKD It also aimed to assess whether lowering LDL cholesterol reduced the rate of loss of renal function in people with CKD who had not commenced dialysis treatment
Detailed Description:
The SHARP Study of Heart and Renal Protection was a double-blind placebo-controlled trial which aimed to assess the safety and efficacy of reducing LDL cholesterol in more than 9000 patients with chronic kidney disease about 3000 of whom were on dialysis at randomization
Patients were randomly assigned to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo a subset of these patients had previously received simvastatin 20mg only and were then randomly re-assigned to receive simvastatin 20mg plus ezetimibe 10mg or placebo at one year Details of the SHARP trial design and methods have been reported previously reference Am Heart J 2010 160785-94
SHARP was overseen by an independent Steering Committee that included nephrologists cardiologists clinical trialists and statisticians with 2 non-voting observers from the main funder MerckSchering-Plough Pharmaceuticals The independent sponsor was the University of Oxford and the trial was funded by MerckSchering-Plough Pharmaceuticals the Australian National Health and Medical Research Council the British Heart Foundation and the UK Medical Research Council
In October 2009 the Steering Committee decided blind to the effects of study treatment on clinical outcomes to change the original protocol-specified primary outcome to a revised key outcome of major atherosclerotic events defined as the combination of non-fatal myocardial infarction coronary death ischemic stroke or any revascularization procedure ie exclusion of non-coronary cardiac deaths and strokes confirmed to be hemorrhagic from the original major vascular event outcome These and other changes are described in the revised statistical analysis plan for SHARP reference Am Heart J 2010 160785-94 Accordingly the chief emphasis of the published results reference Lancet 2011 3772181-92 is on the revised pre-specified key outcome of first major atherosclerotic events
Patients were randomly assigned to simvastatin 20 mg plus ezetimibe 10 mg daily versus matching placebo a subset of these patients had previously received simvastatin 20mg only and were then randomly re-assigned to receive simvastatin 20mg plus ezetimibe 10mg or placebo at one year Details of the SHARP trial design and methods have been reported previously reference Am Heart J 2010 160785-94
SHARP was overseen by an independent Steering Committee that included nephrologists cardiologists clinical trialists and statisticians with 2 non-voting observers from the main funder MerckSchering-Plough Pharmaceuticals The independent sponsor was the University of Oxford and the trial was funded by MerckSchering-Plough Pharmaceuticals the Australian National Health and Medical Research Council the British Heart Foundation and the UK Medical Research Council
In October 2009 the Steering Committee decided blind to the effects of study treatment on clinical outcomes to change the original protocol-specified primary outcome to a revised key outcome of major atherosclerotic events defined as the combination of non-fatal myocardial infarction coronary death ischemic stroke or any revascularization procedure ie exclusion of non-coronary cardiac deaths and strokes confirmed to be hemorrhagic from the original major vascular event outcome These and other changes are described in the revised statistical analysis plan for SHARP reference Am Heart J 2010 160785-94 Accordingly the chief emphasis of the published results reference Lancet 2011 3772181-92 is on the revised pre-specified key outcome of first major atherosclerotic events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UK CRN 2542 | OTHER | United Kingdom Clinical Research Network | None |
| ISRCTN54137607 | OTHER | None | None |
| EudraCT - 2004-001156-37 | OTHER | None | None |