Comparing the effects of Sotagliflozin and Empagliflozin on blood clot formation
SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin
This study is testing whether a new diabetes medication called Sotagliflozin can help prevent blood clots better than the standard medication Empagliflozin in people with heart failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06618976 on ClinicalTrials.gov |
What this trial studies
This study investigates the antithrombotic activities of Sotagliflozin, a dual SGLT1/2 inhibitor, compared to Empagliflozin, a standard SGLT2 inhibitor, in patients with heart failure. The research aims to determine whether Sotagliflozin can reduce thrombus formation more effectively than Empagliflozin, potentially offering a safer treatment option for patients at risk of thrombosis. Participants will be monitored for changes in their thrombogenic profile, with a focus on cardiovascular outcomes. The study includes adult volunteers who are disease-free and able to provide informed consent.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are free from significant medical conditions and can provide informed consent.
Not a fit: Patients with a history of significant cardiovascular or other serious diseases, or those currently taking certain medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for heart failure patients by reducing the risk of thrombotic events.
How similar studies have performed: Previous studies have shown that SGLT2 inhibitors can reduce major cardiovascular events, but the specific approach of dual SGLT1/2 inhibition with Sotagliflozin is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects are eligible if they meet all of the following criteria: * Male or female volunteers older than 18 years old. * Disease-free as assessed by medical history and physical examination. * Ability to provide signed informed consent. Exclusion criteria: Subjects will be excluded if they meet any of the following criteria: * Pregnant or lactating women * History of clinically relevant cardiovascular, pulmonary, hepatic, gastrointestinal, renal, metabolic, hematologic, neurologic, respiratory or psychiatric disease, bleeding, acute infectious disease or signs of acute illness. * Use of medication within one month prior to study drug administration or within six times the elimination half-life (whichever is longer), except for oral contraceptives or occasional use of acetaminophen or an antihistamine. * History of drug abuse or alcohol consumption \>20 g/day \[125 ml (30ml=1oz) glass of 10% wine = 12.5 g, 40 mL aperitif of 40% = 17 g, 250 mL glass of 6% beer = 15g\] * Loss of \>400 mL blood or blood donation within 3 months. * Conditions associated with hemorrhagic risk, e.g., frequent epistaxis, gastrointestinal ulcer, hemorrhagic vascular lesions, recent surgery.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Juan J Badimon — Icahn School of Medicine at Mount Sinai
- Study coordinator: Juan J Badimon
- Email: juan.badimon@mssm.edu
- Phone: (212) 241-8484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.