Status:
COMPLETED
The Effect of Dapagliflozin on Platelet Function testinG Profiles in Diabetic PatiEnts.
Lead Sponsor:
The University of The West Indies
Conditions:
Platelet Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ha...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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,
- body weight \<60 kg,
- age \>75 years,
- hemoglobin \<10 g/dL,
- platelet count \<100×106/μL,
- creatinine \>2 mg/dL,
- hepatic enzymes \>2.5 times the upper limit of normal,
- pregnancy and/or lactation.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04400760
Start Date
May 1 2020
End Date
June 30 2022
Last Update
November 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Eric Williams Medical Sciences Complex
Port of Spain, North Central, Trinidad and Tobago, 00000