Clinical trial NCT06618976: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin
Official title: SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Thrombosis
Keywords: Thrombosis
Platelets
Heart failure
SGLT2
SGLT1/2
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Thrombus size
timeFrame: Baseline and end of each treatment period (1 month and 3 months)
Secondary outcomes:
measure: Platelet aggregation
timeFrame: Baseline and end of each treatment period (1 month and 3 months)
measure: Clot formation size
timeFrame: Baseline and end of each treatment period (1 month and 3 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Juan J Badimon
role: PRINCIPAL_INVESTIGATOR
References: