NCT06933056 · University of Michigan
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
What this study is about
This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.
View original scientific description
This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.
Interventions
DRUG
Sotagliflozin (SOTA) followed by 3 drugs in a random order
400 mg/day SOTA Each drug will be given daily for 2 weeks.
DRUG
Aspirin followed by 3 drugs in a random order
81 mg/day Aspirin Each drug will be given daily for 2 weeks.
DRUG
Clopidogrel followed by 3 drugs in a random order
75 mg/day clopidogrel Each drug will be given daily for 2 weeks.
DRUG
Eliquis followed by 3 drugs in a random order
5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.
Primary outcome measures
Platelet aggregation
Time frame: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.
Measured from blood samples
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Ann Arbor, Michigan
Collaborators
Lexicon Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 15, 2025 · Source of record for eligibility and locations