Phase 3
N=40
The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.
Platelet Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT04400760 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx — 160.93 PRU
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DAPA Tx (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of The West Indies
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx |
160.93 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- between 18 and 74 years of age,
- have stable coronary artery disease and diabetes mellitus, already on DAPT with aspirin and clopidogrel for at least 6 months,
- not on any physician-prescribed medications or complementary/alternative therapies.
Exclusion Criteria
- presence of active internal bleeding or history of bleeding diathesis or clinical findings associated with an increased risk of bleeding,
- history of ischemic or hemorrhagic stroke, transient ischemic attack, intracranial neoplasm, arteriovenous malformation, or aneurysm,
- history of clinical and/or hemodynamic instability,
- within 1 month of placement of a bare-metal stent,
- within 30 days of coronary artery bypass graft surgery or PCI without a stent placed,
- planned coronary revascularization,
- treatment with fibrin-specific fibrinolytic therapy 1.5,
- body weight 75 years,
- hemoglobin 2 mg/dL,
- hepatic enzymes >2.5 times the upper limit of normal,
- pregnancy and/or lactation.
Data sourced from ClinicalTrials.gov (NCT04400760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.