CompletedPhase 2/3

The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.

Trinidad and Tobago40 participantsStarted 2020-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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

What they're measuring

Platelet Reactions Units Pre-DAPA Tx and Post-DAPA Tx

Timeframe: Baseline (0 weeks) to Completion (2 weeks) after Dapagliflozin

Trial details

NCT IDNCT04400760

SponsorThe University of The West Indies

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

Results submitted2023-09-21

View on ClinicalTrials.gov More Platelet Dysfunction trials