The Evaluation of Bococizumab (PF-04950615;RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-1)

Phase 3

• Conditions: Health Condition 1: null- Cardiovascular Events /Disease

• Registration Number: CTRI/2015/07/005955
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 17000

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

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.

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 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 Outcome Measures

Name	Time	Method
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