Atherosclerotic Cardiovascular Disease Clinical Trial
Official title:
A Randomized, Double-Blind Placebo- Controlled Phase 2a Study to Assess the Effect of CCR2 Antagonism by MLN1202 on Atherosclerotic Inflammation in Subjects With Stable Atherosclerotic Cardiovascular Disease Using FDG PET/CT Imaging
The purpose of this study is to evaluate the effect of MLN1202 on arterial inflammation in participants with stable atherosclerotic cardiovascular disease (CVD) who are receiving standard-of-care (SOC) therapy.
The drug being tested in this study is called MLN1202. MLN1202 is being tested to treat
people who have stable atherosclerotic cardiovascular disease (CVD). This study will look at
changes in arterial inflammation in people who take MLN1202 in addition to standard-of-care
(SOC) therapy.
The study will enroll approximately 108 participants. Participants will be randomly assigned
(by chance, like flipping a coin) to one of the two treatment groups—which will remain
undisclosed to the patient and study doctor during the study (unless there is an urgent
medical need):
- MLN1202 Dose A intravenously (IV)
- Placebo (dummy inactive solution) - this is a solution that looks like the study drug
but has no active ingredient
All participants will receive IV administration of MLN1202 or placebo on Day 1, Day 29, and
Day 57 of this study.
This multi-centre trial will be conducted in the United States. The overall time to
participate in this study is 19 weeks. Participants will make 7 visits to the clinic, and
will be contacted by telephone approximately 35 days after last dose of study drug for a
follow-up assessment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| 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 | |
| Active, not recruiting |
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 | |
| Active, not recruiting |
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 |