ThrombosisPhase 4SOTATHROMBUSNCT06618976
Antithrombotic Activities of Sotagliflozin vs. Empagliflozin
A Phase 4 study testing Sotagliflozin and Empagliflozin in people with Thrombosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- Sotagliflozin and Empagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 10 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin
The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.
- Conditions
- Thrombosis
- Being tested
- Sotagliflozin, Empagliflozin
- Keywords
- Thrombosis, Platelets, Heart failure, SGLT2, SGLT1/2
- Medical subject headings
- Thrombosis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotagliflozinDrug
Sotagliflozin 400 mg, P.O. once daily for 1 month.
EmpagliflozinDrug
Empagliflozin 10 mg, P.O. once daily for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Sotagliflozin then Empagliflozin | Other | Subjects randomized to 'Arm A' will receive 1-month of 'Sotagliflozin' treatment first and then 1-month of 'Empagliflozin' treatment second, separated by a 1-month of washout period. Receives: Drug: Sotagliflozin; Drug: Empagliflozin |
| Empagliflozin then Sotagliflozin | Other | Subjects randomized to 'Arm B' will receive1-month of 'Empagliflozin' treatment first and then1-month of 'Sotagliflozin' treatment second, separated by a 1-month of washout peri od Receives: Drug: Sotagliflozin; Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombus size
Changes in blood thrombogenicity (thrombus size) from baseline to post-treatment
Measured: Baseline and end of each treatment period (1 month and 3 months)
Secondary outcomes (2)
Platelet aggregation
A platelet aggregation is a blood test that looks at the reactivity of platelets.
Measured: Baseline and end of each treatment period (1 month and 3 months)
Clot formation size
The size of the clot will be assessed in whole blood samples using a thromboelastometry
Measured: Baseline and end of each treatment period (1 month and 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start25 Feb 2025
- Primary completion10 Feb 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Badimon, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan J Badimon, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618976
- Sponsor's protocol ID
- STUDY-24-00304
- Acronym
- SOTATHROMBUS
- Status last verified
- Apr 2026
- First submitted
- 19 Sep 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Requena-Ibanez JA, Zafar MU, Ferrandez-Escarabajal M, Escolar G, Santos-Gallego C, Lam D, Badimon JJ. Rationale and Design of the SOTA-THROMBOSIS Trial (ATRU-VI): Antithrombotic Activities of Sotagliflozin Compared With Empagliflozin. J Cardiovasc Pharmacol. 2025 Nov 1;86(5):458-462. doi: 10.1097/FJC.0000000000001747.
PubMed 40748666
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin
- ClinicalTrials.gov ID
- NCT06618976
- Acronym / sponsor ID
- SOTATHROMBUS / STUDY-24-00304
- Conditions
- Thrombosis
- Keywords
- Thrombosis, Platelets, Heart failure, SGLT2, SGLT1/2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotagliflozin then Empagliflozin | Other | Drug: Sotagliflozin, Drug: EmpagliflozinSubjects randomized to 'Arm A' will receive 1-month of 'Sotagliflozin' treatment first and then 1-month of 'Empagliflozin' treatment second, separated by a 1-month of washout period. |
| Empagliflozin then Sotagliflozin | Other | Drug: Sotagliflozin, Drug: EmpagliflozinSubjects randomized to 'Arm B' will receive1-month of 'Empagliflozin' treatment first and then1-month of 'Sotagliflozin' treatment second, separated by a 1-month of washout peri od |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotagliflozinSotagliflozin 400 mg, P.O. once daily for 1 month. | Drug | Empagliflozin then Sotagliflozin, Sotagliflozin then Empagliflozin |
| EmpagliflozinEmpagliflozin 10 mg, P.O. once daily for 1 month. | Drug | Empagliflozin then Sotagliflozin, Sotagliflozin then Empagliflozin |
Primary outcome
Thrombus size
Time frame: Baseline and end of each treatment period (1 month and 3 months)
Changes in blood thrombogenicity (thrombus size) from baseline to post-treatment
2 secondary outcomes
Platelet aggregation
Time frame: Baseline and end of each treatment period (1 month and 3 months)
Clot formation size
Time frame: Baseline and end of each treatment period (1 month and 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 40748666Requena-Ibanez JA, Zafar MU, Ferrandez-Escarabajal M, Escolar G, Santos-Gallego C, Lam D, Badimon JJ. Rationale and Design of the SOTA-THROMBOSIS Trial (ATRU-VI): Antithrombotic Activities of Sotagliflozin Compared With Empagliflozin. J Cardiovasc Pharmacol. 2025 Nov 1;86(5):458-462. doi: 10.1097/FJC.0000000000001747.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan J Badimon principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sotagliflozin and Empagliflozin in people with Thrombosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombus size (time frame: Baseline and end of each treatment period (1 month and 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06618976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.