Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

NCT ID: NCT06618976

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2026-02-27

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 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.

Conditions

Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sotagliflozin then Empagliflozin

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 Type: OTHER

Sotagliflozin

Intervention Type: DRUG

Sotagliflozin 400 mg, P.O. once daily for 1 month.

Empagliflozin

Intervention Type: DRUG

Empagliflozin 10 mg, P.O. once daily for 1 month.

Empagliflozin then Sotagliflozin

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

Group Type: OTHER

Sotagliflozin

Intervention Type: DRUG

Sotagliflozin 400 mg, P.O. once daily for 1 month.

Empagliflozin

Intervention Type: DRUG

Empagliflozin 10 mg, P.O. once daily for 1 month.

Interventions

Sotagliflozin

Sotagliflozin 400 mg, P.O. once daily for 1 month.

Intervention Type: DRUG

Empagliflozin

Empagliflozin 10 mg, P.O. once daily for 1 month.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Juan Badimon

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan J Badimon

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Juan J Badimon

Role: CONTACT

juan.badimon@mssm.edu

(212) 241-8484

Mohammad U Zafar

Role: CONTACT

urooj.zafar@mssm.edu

(212) 241-8484

Facility Contacts

Juan J Badimon

Role: primary

juan.badimon@mssm.edu

(212) 241-8484

Mohammad U Zafar

Role: backup

urooj.zafar@mssm.edu

(212) 241-8484

Other Identifiers

STUDY-24-00304

Identifier Type: -

Identifier Source: org_study_id