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New treatment option for Platelet Function and Reactivity Tests
Official title Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
ClinicalTrials.gov ID: NCT06933056
What this study is testing
What is Sotagliflozin (SOTA) followed by 3 drugs in a random order?
Sotagliflozin (SOTA) followed by 3 drugs in a random order is an investigational medicine, given as an once-daily, being studied as a potential treatment for platelet function and reactivity tests.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79. Healthy volunteers may be eligible.
You likely can't join if
- Students under the direct supervision of Dr. Michael Holinstat
- people diagnosed with Type I diabetes or those with ketoacidosis
- people with a history of alcohol abuse, pancreatitis or pancreatic surgery, or people 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...
- people 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...
See the full eligibility criteria
- Students under the direct supervision of Dr. Michael Holinstat
- people diagnosed with Type I diabetes or those with ketoacidosis
- people with a history of alcohol abuse, pancreatitis or pancreatic surgery, or people 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...
- people 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
- people 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...
- 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)...
- people less than or equal to 60 kg will be excluded
- people with a creatinine greater than or equal to 1.5 mg/dl will be excluded
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.