Atherosclerotic Cardiovascular Disease Clinical Trial
Official title:
Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial
Although the clinical efficacy of LDL-cholesterol lowering therapy has been proven with strong evidences and emphasized, there are also growing concerns that intensive lipid-lowering therapy would be related to increased risk of adverse effects. In addition, statin potency from recent guidelines was set from the studies composed of mainly Caucasian population, although there is an inconsistency of statin effect according to ethnicity. Asian population showed more profound LDL reduction not only from high potent statin but also from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate LDL-cholesterol levels. Adding ezetimibe will be an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to achieve sufficient LDL-cholesterol lowering effect. However, studies regarding the effect of intensive-targeting of lipid-lowering therapy and therapy regimens are lacking. Thus, on these basis, we sought to evaluate whether intensive-targeting of lipid-lowering therapy will have more prominent beneficial effect compared to conventional-targeting in patients with documented ASCVD with either an ezetimibe/statin combination therapy or a statin monotherapy.
All eligible patients who have documented ASCVD will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent. At the time of enrollment, we will stratify all patients according to LDL-cholesterol <100mg/dL, DM, and acute coronary syndrome, and randomly assign them in two groups according to LDL-cholesterol targeting level with a 1:1 ratio: "Intensive-targeting group" vs. "Conventional-targeting group". In addition, patients in each group will be randomly assigned to receive two lipid-lowering therapy regimen with a 1:1 ratio: "Ezetimibe/Statin combination therapy" vs. "Statin monotherapy". Patients allocated to each treatment group will receive lipid-lowering therapy with following protocols. ;
| 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
|
||
| Active, not recruiting |
NCT05030428 -
Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease
|
Phase 3 | |
| 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 |