CompletedPhase 2/3

The Effect of empagliFlozin on Platelet Function profilEs in diabetiC patienTs - The EFFECT Study.

Trinidad and Tobago25 participantsStarted 2020-01-01

Plain-language summary

The mechanistic effects of empagliflozin on platelet function profiles have not yet been ascertained.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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,

✕. 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 \<24 h or non-fibrin-specific fibrinolytic therapy \<48 h,
✕. use of an oral anticoagulation agent or international normalized ratio \>1.5,

P2Y12 Reaction Units

Timeframe: 14 days

NCT IDNCT04342819

SponsorThe University of The West Indies

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Results submitted2023-08-25