Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Sep 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two medications, sotagliflozin and empagliflozin, on blood clot formation, which is important for people with heart conditions. The researchers want to see if sotagliflozin, a newer drug that works on two types of receptors, can reduce the risk of blood clots better than empagliflozin, which is a standard treatment. The trial will involve healthy volunteers who are over 18 years old and do not have any major health issues. Participants will take both medications at different times and will be monitored to see how their blood responds.

To be eligible for this study, volunteers must be free of significant health problems and able to give consent. However, those who are pregnant, have certain medical conditions, or have recently taken other medications may not be able to participate. Throughout the trial, participants can expect to undergo various tests to measure how well their blood is clotting after taking each medication. This trial is currently recruiting participants and aims to provide valuable information that could help improve treatment options for patients with cardiovascular diseases.

Gender

ALL

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.