drugset / Trial / NCT02302508

Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients

NCT02302508

RandomizedCrossoverTriple-blindBasic science

Summary

Clopidogrel efficacy appears diminished in patients with type 2 diabetes (T2D) who continue to show an increased risk of adverse cardiovascular events and mortality compared to those without T2D.The aim of the first project is to describe the pharmacokinetic (PK) profile of three antiplatelet drugs in 4 groups of patients according to their diabetic or non-diabetic status. To this end, PK profiles will be determined after a single oral dose of 300 mg clopidogrel, 60 mg prasugrel and 180 mg ticagrelor in patients (n=108); 1) with T2D and good glycemic control; 2) with T2D and poor glycemic control; 3) with insulin-treated diabetes; and 4) non-diabetic subjects.

Timeline

Start
2019-09-01
Primary completion
2020-12
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Clopidogrel Small molecule 300 mg Oral
Subject Prasugrel Small molecule 60 mg Oral
Subject Ticagrelor Small molecule 180 mg Oral

Indications