Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618976
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Antithrombotic Activities of Sotagliflozin vs Empagliflozin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SOTA-THROMBOSIS Antithrombotic Activities of Sotagliflozin vs Empagliflozin
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOTATHROMBUS
Brief Summary:
The availability of Sodium-glucose cotransporter-2 inhibitors SGLT2-i has dramatically altered the management of heart failure HF patients independently of their ejection fraction and glycemic status A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs placebo or active comparator showed reductions in major cardiovascular events but no impact on atherothrombotic events In fact a non-significant increase in the risk for non-fatal stroke was observed Similar trend observed in multiple trials indicate a SGLT2-i class effect Sotagliflozin is the first dual SGLT12 receptor inhibitor that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients suggesting that dual SGLT12 inhibitor may have additional properties vs SGLT2-i The hypothesis of this study is that dual SGLT12 inhibition by sotagliflozin improves thrombogenic profile ie reduces thrombus formation which could make it a safer and more effective treatment option for cardiovascular CV patients than SGLT2-i To test the hypothesis the researchers will compare the antithrombotic activity of sotagliflozin vs empagliflozin in healthy volunteers using a randomized cross-over study design where each participant will receive both study treatments sotagliflozin and empagliflozin separated by a washout period Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber platelet aggregation using Multiplate Analyzer and Thromboelastometry using RoTEM Gamma Study assessments will be performed before initiating baselinepre-treatment and after completion of each treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None