drugset / Trial / NCT02302508
Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients
Phase 4
Withdrawn
University of Montreal Hospital Centre (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clopidogrel | Small molecule | 300 mg | Oral |
| Subject | Prasugrel | Small molecule | 60 mg | Oral |
| Subject | Ticagrelor | Small molecule | 180 mg | Oral |