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Sodium GLucose Transport 2 inhibitors (SGLT2I), including dapagliflozin, 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 dapagliflozin on platelet function profiles have not yet been ascertained. It remains unclear if this reduction in cardiovascular death is mediated by decreased platelet reactivity.
Diabetes is highly prevalent in our setting. Dapagliflozin is now considered first-line treatment for diabetes, especially in the cardiovascular arena. The standard prescribed dosages of dapagliflozin will be employed in the research study (5 or 10 mg once daily). The reason the study team is interested in performing this study in our local setting is that if dapagliflozin does show a beneficial effect with either diabetic control or an antiplatelet effect, the team can then inform the Ministry of Health to acquire these relatively expensive medications in place of the older, less effective anti-diabetic drugs. The team has to demonstrate that they work effectively and safely in our population before approaching regulatory bodies with a robust recommendation that they are made available in the public healthcare sector. The patients that are to be selected will be relatively controlled on their current regimen, and thus not "miss out" on these medications after the study has been concluded as they are all available on the chronic disease assistance program (CDAP) such as metformin, gliclazide and insulin therapies. The study will aim to determine if dapagliflozin does demonstrate other latent antiplatelet effects that can potentially affect the cardiovascular/hematologic systems that have not investigated before.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPA Tx | Other | This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAPA Tx | Drug | The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx | Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin | Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naveen A Seecheran, MBBS MSc | The University of The West Indies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eric Williams Medical Sciences Complex | Port of Spain | North Central | 00000 | Trinidad and Tobago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34643895 | Derived | Seecheran N, Grimaldos K, Ali K, Grimaldos G, Richard S, Ishmael A, Gomes C, Karan A, Seecheran R, Seecheran V, Persad S, Abdullah H, Peram L, Dookeeram D, Giddings S, Motilal S, Raza S, Tello-Montoliu A, Schneider D. The Effect of Dapagliflozin on Platelet Function Testing Profiles in Diabetic Patients: The EDGE Pilot Study. Cardiol Ther. 2021 Dec;10(2):561-568. doi: 10.1007/s40119-021-00242-6. Epub 2021 Oct 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DAPA Tx | This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks. DAPA Tx: The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DAPA Tx | This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks. DAPA Tx: The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks. |
| 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 | Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx | Platelet Reaction units at baseline and post-DAPA Tx treatment with dapagliflozin | Posted | Mean | 95% Confidence Interval | PRU | Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin |
|
|
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 | DAPA Tx | This arm will comprise the participants who are administered Dapagliflozin 10mg per oral once daily for 2 weeks. DAPA Tx: The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naveen Seecheran | The University of the West Indies, St. Augustine | 18687537686 | nseecheran@gmail.com |
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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 | May 1, 2020 | Oct 16, 2023 | Prot_SAP_001.pdf |
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The study will be of a prospective, open-label trial design over a 2-year period. Patients at the Eric Williams Medical Sciences Complex (EWMSC), Mt. Hope, Trinidad and Tobago will be screened for potential eligibility.
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PRU | Mean | Standard Deviation | PRU |
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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