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Recruiting NCT06933056

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs

Early Phase I Interventional Platelet Function and Reactivity Tests

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sotagliflozin (SOTA) followed by 3 drugs in a random order, Aspirin followed by 3 drugs in a random order, Clopidogrel followed by 3 drugs in a random order, Eliquis followed by 3 drugs in a random order.
Who it may be relevant to
Registry conditions: Platelet Function and Reactivity Tests. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

Overview

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.]
Secondary outcome measures (4)
  • Platelet granule secretion [Time frame: Blood will be drawn and granule secretion measured at baseline (day 1) and every 14 days.]
  • Total thrombus activation with T-TAS [Time frame: Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days.]
  • Thromboelastography (TEG) [Time frame: Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days.]
  • Platelet integrin activation [Time frame: Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days.]

Eligibility criteria

Inclusion criteria

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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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Michigan — Ann Arbor

Identifiers

NCT: NCT06933056 · HUM00267102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗