Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborator: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
• Treatments: Clopidogrel; Platelet Aggregation Inhibitors; Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

• Participants will be ≥18 years old

• Non-smokers (>3 months)

• T2D with good glycemic control A1C<7.0

• T2D with poor glycemic control A1C >7.5

• Insulin-treated T2D

• Non-diabetic healthy subjects

Exclusion Criteria:

• Subjects with estimated glomerular filtration (MDRD) <50 mL/min/1.73m2

• ALT and AST 3 times above the upper limit of normal

• Organ transplant recipients

• Inflammatory illnesses (i.e., polyarthritis, hepatitis, cirrhosis, active infectious diseases)

• Active cancer (except non-melanoma skin cancer)

• Uncontrolled thyroid functions

• Inflammatory bowel diseases (ulcerous colitis and Crohn's disease), bariatric surgery

• Pregnancy

• History of drug or alcohol abuse

• Platelet function disorder,

• One of the following therapies : P2Y12 inhibitors, antithrombotics, antibiotics, anticoagulant, antivirals, CYP450 inducers (carbamazepine, phenobarbital, phenytoin, rifampin, St-John's worth), CYP450 inhibitors (amiodarone, fluoxetine, verapamil), immunosuppressors, INFs, or grapefruit juice (<4 weeks) or an investigational drug

• Intolerance or hypersensitivity to antiplatelet drugs or their excipients