Sotagliflozin vs. Empagliflozin for Blood Clots

(SOTATHROMBUS Trial)

Overseen By Mohammad U Zafar

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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 SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. 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 (baseline/pre-treatment) and after completion of each treatment.

Research Team

Juan J Badimon

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for healthy volunteers interested in contributing to research on heart failure treatments. Participants will be involved in a study comparing two drugs, Sotagliflozin and Empagliflozin, which may affect blood clotting differently.

Inclusion Criteria

Ability to provide signed informed consent

I am over 18 years old.

I am currently free from any signs of disease, as confirmed by my doctor.

Exclusion Criteria

Pregnant or lactating women

History of drug abuse or alcohol consumption exceeding 20 g/day

I have no significant ongoing health issues besides my current condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1-month of Sotagliflozin treatment followed by a 1-month washout period, then 1-month of Empagliflozin treatment

3 months

Visits at baseline, end of each treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Empagliflozin
• Sotagliflozin

Trial Overview Researchers are testing whether Sotagliflozin, a dual inhibitor affecting glucose transporters, can better prevent blood clots compared to Empagliflozin in cardiovascular patients. The study uses a cross-over design where participants receive both drugs at different times.

Participant Groups

Group I: Sotagliflozin then Empagliflozin Experimental Treatment 2 Interventions

Subjects randomized to 'Arm A' will receive 1-month of 'Sotagliflozin' treatment first and then 1-month of 'Empagliflozin' treatment second, separated by a 1-month of washout period.

Group II: Empagliflozin then Sotagliflozin Experimental Treatment 2 Interventions

Subjects randomized to 'Arm B' will receive1-month of 'Empagliflozin' treatment first and then1-month of 'Sotagliflozin' treatment second, separated by a 1-month of washout peri od

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in United States as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease
• Cardiovascular risk reduction

Approved in Canada as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in Japan as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+