Antithrombotic Activities of Sotagliflozin vs. Empagliflozin (SOTATHROMBUS)

Mount Sinai Health System

Status and phase: Begins enrollment this month; Phase 4

Conditions: Thrombosis

Treatments: Drug: Sotagliflozin; Drug: Empagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT06618976

STUDY-24-00304

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Sotagliflozin then Empagliflozin

Other group

Description:

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.

Treatment:

Drug: Empagliflozin

Drug: Sotagliflozin

Empagliflozin then Sotagliflozin

Other group

Description:

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

Treatment:

Drug: Empagliflozin

Drug: Sotagliflozin