Atherosclerosis Clinical Trial
Official title:
CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)
This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in patients who have pre-diabetes and heart or blood vessel problems.
CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in patients with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA1c, fasting blood glucose, or oral glucose tolerance test criteria; clinically evident coronary, cerebrovascular, or peripheral arterial atherosclerotic cardiovascular disease; and estimated glomerular filtration rate of at least 45 mL/min/1.73 m2; and do not fulfill any exclusion criteria. Patients who are eligible and agree to participate are randomly assigned to treatment with metformin XR (titrated to a maximum dose of 2000 mg daily based on safety and tolerability) or matching placebo. All patients receive counseling on therapeutic lifestyle recommendations. CSP #2002 had a Pilot Phase trial from 2/2019 to 1/2021 and was approved for the full-scale trial, with projected full-scale launch in 10/2022. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05052918 -
The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes
|
N/A | |
| Recruiting |
NCT04511234 -
Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease
|
N/A | |
| Completed |
NCT05906797 -
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
|
N/A | |
| Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
| Suspended |
NCT02932176 -
Machine Learning for Handheld Vascular Studies
|
||
| Recruiting |
NCT05158257 -
Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity
|
N/A | |
| Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
| Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
| Recruiting |
NCT06230406 -
T-Mem GEne in Atherosclerosis
|
||
| Completed |
NCT03654313 -
Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus
|
Phase 1 | |
| Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
| Recruiting |
NCT02894931 -
Effects of Dietary Interventions on Serum and Macrophage Atherogenicity
|
N/A | |
| Completed |
NCT02998918 -
Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL
|
N/A | |
| Not yet recruiting |
NCT02578355 -
National Plaque Registry and Database
|
N/A | |
| Recruiting |
NCT02265250 -
Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
|
||
| Completed |
NCT02268513 -
Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
|
||
| Completed |
NCT02224339 -
New Technologies to Determine Carotid Plaque Vulnerability
|
||
| Completed |
NCT03393377 -
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
|
N/A | |
| Not yet recruiting |
NCT01923012 -
Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis
|
Phase 2 | |
| Completed |
NCT02377310 -
Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography
|
N/A |