â??The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-2)â??
- Conditions
- Health Condition 1: null- Cardiovascular Events /Disease
- Registration Number
- CTRI/2015/07/005954
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 9000
1.Must be on background lipid lowering treatment.
2.Must be at high risk of a CV event.
3.Must have an LDL C greater than or equals to 100 mg/dL (2.6 mmol/L) OR non HDL C greater than or equals to 130 mg/dL (3.4 mmol/L).
1.An LDL C less than 100 mg/dL (2.6 mmol/L) or non HDL C less than 130 mg/dL (3.4 mmol/L).
2.Planned coronary (PCI or CABG) or other arterial revascularization.
3.New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction less than 25% by cardiac imaging.
4.Chronic renal insufficiency with creatinine clearance of less than 30 ml/min/1.73m to the power of 2 by MDRD formula or with end state renal disease on dialysis.
5.History of hemorrhagic stroke.
6.Prior exposure to bococizumab or other investigational PCSK9 inhibitor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiovascular event <br/ ><br>â?¢Confirmed occurrence of a major cardiovascular event, a composite endpoint which includes CV death, non fatal MI, non fatal stroke, and hospitalization for unstable angina needing urgent revascularizationTimepoint: The time from Randomization to the first adjudicated and confirmed occurrence of a primary endpoint major cardiovascular event, up to Month 60.
- Secondary Outcome Measures
Name Time Method A composite endpoint of all-cause death, non fatal MI, and non fatal stroke, and hospitalization for unstable angina needing urgent revascularization.Timepoint: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, and non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization, assessed up to M60;A composite endpoint of CV death, non fatal MI, and non fatal strokeTimepoint: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke, assessed up to Month 60;Hospitalization for unstable angina needing urgent revascularizationTimepoint: The time from randomization to the first adjudicated and confirmed hospitalization for unstable angina needing urgent revascularization, assessed up to Month 60