Alirocumab and Ischemic Risk in Atherosclerotic Cardiovascular Disease (ASCVD)
NCT07615179 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2214
Last updated 2026-05-29
Summary
The objective of this study is to evaluate ischemic event rates among individuals with established atherosclerotic cardiovascular disease without prior acute ischemic events, comparing those treated with alirocumab versus those receiving no proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) therapy. The study will leverage observational data reflective of routine clinical practice and will apply contemporary approaches in target trial emulation and causal inference to estimate treatment effects.
Conditions
- Atherosclerotic Cardiovascular Disease Without Prior Ischemic Events
Interventions
- DRUG
-
Alirocumab
The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.
- DRUG
-
Comparator: No PCSK9i Therapy (either mAb or siRNA)
The study will not administer any treatment, only observe the treatment as prescribed in routine clinical practice.
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-17
- Primary Completion
- 2026-05-30
- Completion
- 2026-05-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
NCT05739383 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
NCT00414609 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome
NCT00658515 ·Status: COMPLETED ·Phase: PHASE3
-
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
NCT01327846 ·Status: COMPLETED ·Phase: PHASE3
-
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
NCT06909565 ·Status: RECRUITING ·Phase: PHASE4
-
Potential Eligibility and Estimated Preventable Cardiovascular Disease Events From Inclisiran Treatment in the United States
NCT07214857 ·Status: COMPLETED
-
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
NCT05918861 ·Status: RECRUITING ·Phase: PHASE3
-
A Study of RO4905417 in Patients With Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention
NCT01327183 ·Status: COMPLETED ·Phase: PHASE2
-
In-hospital Initiation of PCSK9 Inhibitor in Patients With Acute Myocardial Infarction
NCT05184530 ·Status: COMPLETED
-
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
NCT04873934 ·Status: COMPLETED ·Phase: PHASE3
-
Hexadecasaccharide (SR123781A) in Patients With Unstable Angina or Non-ST-Segment Elevation Myocardial Infarction
NCT00123565 ·Status: COMPLETED ·Phase: PHASE2
-
Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients
NCT00379418 ·Status: COMPLETED
-
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
NCT05030428 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 Antibody
NCT04141579 ·Status: COMPLETED ·Phase: NA
-
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
NCT03400800 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients
NCT01020383 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
NCT00809965 ·Status: COMPLETED ·Phase: PHASE3
-
Nitric Oxide in Myocardial Infarction Size
NCT00568061 ·Status: TERMINATED ·Phase: PHASE2
-
TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
NCT07052903 ·Status: RECRUITING ·Phase: PHASE3
-
Very Early PCSK9 Inhibition for Acute Myocardial Infarction
NCT07208006 ·Status: RECRUITING ·Phase: NA
-
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary Artery Disease (FORWARD)
NCT04087915 ·Status: UNKNOWN
-
Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant
NCT06563895 ·Status: RECRUITING ·Phase: PHASE3
-
Phase III Acute Coronary Syndrome
NCT00831441 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of SRSD107 in Participants With Chronic Coronary and/or Peripheral Arterial Disease
NCT07318155 ·Status: RECRUITING ·Phase: PHASE2
-
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke
NCT03872401 ·Status: COMPLETED ·Phase: PHASE3