Sotagliflozin compared with aspirin, clopidogrel, and apixaban for platelet activation
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study
This study will test if sotagliflozin can reduce platelet activation as well as commonly used antiplatelet drugs in adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06933056 on ClinicalTrials.gov |
What this trial studies
This early-phase, interventional crossover trial at the University of Michigan compares the effects of sotagliflozin to three FDA-approved antiplatelet drugs (aspirin, clopidogrel, and apixaban) on platelet function. Participants receive each drug in a randomized order with platelet function and reactivity tests performed after each drug administration. The trial is designed to identify whether sotagliflozin modulates platelet activation similarly to standard antiplatelet agents. Results will inform whether further development or larger trials are warranted.
Who should consider this trial
Good fit: Adults who are not pregnant or breastfeeding, have no active bleeding or bleeding disorders, are not on prohibited NSAIDs or anticoagulants, and do not have hypersensitivity to the study drugs would be appropriate candidates.
Not a fit: People with active bleeding, a history of certain genital or pancreatic infections/procedures, type I diabetes or ketoacidosis, pregnancy or breastfeeding, hypersensitivity to the study drugs, or recent NSAID use are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, sotagliflozin could offer an additional or alternative way to limit platelet activation, potentially benefiting patients who need antiplatelet effects or who may gain dual advantages from the drug's other cardiovascular or metabolic effects.
How similar studies have performed: This is a relatively novel head-to-head comparison: preclinical and observational data suggest SGLT inhibitors may affect platelets, but direct human comparisons to standard antiplatelet drugs are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Exclusion Criteria: * Students under the direct supervision of Dr. Michael Holinstat * Subjects diagnosed with Type I diabetes or those with ketoacidosis * Subjects with a history of alcohol abuse, pancreatitis or pancreatic surgery, or subjects taking a ketogenic diet * Women who self-identify as being pregnant or who are planning to become pregnant during the 14 week study will be excluded from the study, as are those who are breastfeeding (women enrolled in the study will be given a urine pregnancy test at the start of each drug administration period to confirm pregnancy status) * Subjects with hypersensitivity to aspirin, clopidogrel, apixaban, or sotagliflozin are excluded * have active bleeding, or who have who have a history of balanitis or balanoposthitis, genital mycotic infections, or a planned elective surgical/dental procedure 1 month prior to or following completion of study * Subjects who have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDS; examples of NSAIDS are Ibuprofen (Advil, Motrin) and Naproxen (Aleve)) or aspirin within 7 days prior to the study or anticoagulants within 10 days prior to the study * individuals currently taking SSRI's (for example, Fluoxetine (Prozac), Sertraline (Zoloft), Paroxetine (Paxil), Citalopram (Celexa), and Escitalopram (Lexapro).), SNRI's (Duloxetine (Cymbalta), Venlafaxine (Effexor XR), Desvenlafaxine (Pristiq), and Levomilnacipran (Fetzima)), lithium, or omeprazole/esomeprazole * Subjects less than or equal to 60 kg will be excluded * Subjects with a creatinine greater than or equal to 1.5 mg/dl will be excluded
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Michael Holinstat, PhD — University of Michigan
- Study coordinator: Amanda Prieur
- Email: famanda@med.umich.edu
- Phone: 734-763-8824
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.