Atherosclerotic Cardiovascular Disease Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01572259 -
Assessment of the Role of the Growth Hormone (GH) Onthe Intestinal Triglyceride-rich-lipoproteins (TRL) Metabolism
|
Phase 3 | |
| Completed |
NCT05792787 -
Association Between Apical Periodontitis and Atherosclerotic Cardiovascular Diseases
|
||
| Completed |
NCT03911284 -
The Learning Registry
|
||
| Recruiting |
NCT06048588 -
YN001 in Healthy Subjects and Patients With Coronary Atherosclerosis
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03705234 -
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
|
Phase 3 | |
| Completed |
NCT03096288 -
Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity
|
Phase 4 | |
| Enrolling by invitation |
NCT05485961 -
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
|
Phase 2/Phase 3 | |
| Completed |
NCT01663402 -
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
|
Phase 3 | |
| Completed |
NCT03597412 -
Rosuvastatin/Ezetimibe Versus Rosuvastatin in ASCVD Patients With Type 2 DM
|
Phase 4 | |
| Completed |
NCT05974345 -
In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease
|
||
| Completed |
NCT00185185 -
Olmesartan Medoxomil in Atherosclerosis
|
Phase 3 | |
| Completed |
NCT05129241 -
Non-interventional Study on the Monthly Administration of 300 mg AliRocumab (PRALUENT®) With the 2 ml SYDNEY Auto-injector
|
||
| Completed |
NCT02991118 -
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
|
Phase 3 | |
| Completed |
NCT05639244 -
Time Restricted Eating and Innate Immunity
|
N/A | |
| Completed |
NCT02988115 -
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
|
Phase 3 | |
| Recruiting |
NCT04215237 -
How Atorvastatin Affects the Gut Flora and Metabolomics?
|
N/A | |
| Completed |
NCT05355402 -
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
|
Phase 2 | |
| Recruiting |
NCT05726838 -
The Belgian REAL (BE.REAL) Registry
|
||
| Active, not recruiting |
NCT04462159 -
The Young Heart Study
|
N/A | |
| Not yet recruiting |
NCT03505073 -
Association Between Dietary Habits and Risk Factors for Atherosclerotic Cardiovascular Diseases in Assiut Governorate
|