Health Condition 1: null- Cardiovascular Events /Disease
Conditions
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 or equals to 70 mg/dL (1.8 mmol/L) and less than 100 mg/dL (2.6 mmol/L) or non-HDL-C greater or equals to 100 mg/dL (2.6 mmol/L) and less than 130 mg/dL (3.4 mmol/L).
Exclusion criteria
Exclusion criteria: 1.An LDL C less than 70 mg/dL (1.8 mmol/L) or greater or equals to 100 mg/dL (2.6 mmol/L) or non HDL-C less than 100 mg/dL (2.6 mmol/L) or greater or equals to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular event. â?¢Confirmed occurrence of a major cardiovascular event, a composite endpoint that includes CV death, non- fatal MI, 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 primary endpoint major cardiovascular event, up to Month 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 revascularization.Timepoint: The time from randomization to the first adjudicated and confirmed hospitalization for unstable angina needing urgent revascularization, assessed up to Month 60;A composite endpoint of all-cause death, non- fatal MI, and non-fatal stroke, and hospitalization for unstable angina needing urgent revascularizationTimepoint: 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 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactSwapnali Raut
Pfizer Limited
Outcome results
None listed