Phase 3
N=25
The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.
Platelet Dysfunction Due to Drugs
Bottom Line
View on ClinicalTrials.gov: NCT04342819 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: P2Y12 Reaction Units — 187.35 P2Y12 Reaction Units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SGLT2 inhibitor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of The West Indies
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY P2Y12 Reaction Units |
187.35 | — |
Summary
The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.
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,
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 (NCT04342819). 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.