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The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.
Sodium GLucose Transport 2 inhibitors (SGLT2I), including empagliflozin, reduce the likelihood of hospitalization for heart failure and death in persons with type 2 diabetes, of which the mechanism has not been fully elucidated. The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT2i | Experimental | Empagliflozin 25 mg per oral once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitor | Drug | Sodium-Glucose Like Transporter 2 Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| P2Y12 Reaction Units | P2Y12 Reaction Units post-Empagliflozin. Citrated blood samples are processed by CRAs and study investigators. The platelet function assay to be utilized is the VerifyNow P2Y12 (VN-P2Y12) assay (Accriva, San Diego, California). In brief, the VN-P2Y12 assay is a rapid whole blood point-of-care device that reports results as P2Y12 reaction units (PRU) and percent inhibition of platelet aggregation (%IPA). Assays will be performed as per the instructions of the manufacturer previously described. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eric Williams Medical Sciences Complex | Port of Spain | North | 00000 | Trinidad and Tobago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33306161 | Derived | Seecheran N, Ramdeen A, Debideen N, Ali K, Grimaldos K, Grimaldos G, Karan A, Seecheran R, Seecheran V, Persad S, Abdullah H, Peram L, Giddings S, Motilal S, Tello-Montoliu A, Schneider D. The Effect of Empagliflozin on Platelet Function Profiles in Patients with Stable Coronary Artery Disease in Trinidad: The EFFECT Pilot Study. Cardiol Ther. 2021 Jun;10(1):189-199. doi: 10.1007/s40119-020-00208-0. Epub 2020 Dec 11. |
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No enrolled patients were excluded from the study before assignment to empagliflozin.
All participants provided written informed consent to participate in this prospective, open-label study that aimed to assess the effect of empagliflozin 25 mg once daily for 10 days. Patients were screened and enrolled between January 2020 and August 2020 at the cardiology outpatient clinic at our institution (Eric Williams Medical Sciences Complex, Trinidad and Tobago).
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| ID | Title | Description |
|---|---|---|
| FG000 | SGLT2i | Empagliflozin 25 mg per oral once daily SGLT2 inhibitor: Sodium-Glucose Like Transporter 2 Inhibitor |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SGLT2i | Empagliflozin 25 mg per oral once daily SGLT2 inhibitor: Sodium-Glucose Like Transporter 2 Inhibitor |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | P2Y12 Reaction Units | P2Y12 Reaction Units post-Empagliflozin. Citrated blood samples are processed by CRAs and study investigators. The platelet function assay to be utilized is the VerifyNow P2Y12 (VN-P2Y12) assay (Accriva, San Diego, California). In brief, the VN-P2Y12 assay is a rapid whole blood point-of-care device that reports results as P2Y12 reaction units (PRU) and percent inhibition of platelet aggregation (%IPA). Assays will be performed as per the instructions of the manufacturer previously described. | Posted | Mean | 95% Confidence Interval | P2Y12 Reaction Units | 14 days |
|
28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SGLT2i | Empagliflozin 25 mg per oral once daily SGLT2 inhibitor: Sodium-Glucose Like Transporter 2 Inhibitor |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naveen Seecheran, Senior Lecturer | The University of the West Indies | 18687537686 | Naveen.Seecheran@sta.uwi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2020 | Oct 17, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| C570240 | empagliflozin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
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The study will be of a prospective, single-arm, crossover trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago.
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Open-Label
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| P2Y12 Reaction Units (PRU) | Mean | Standard Deviation | P2Y12 Reaction Units (PRU) |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D045505 | Physiological Effects of Drugs |