Status:
WITHDRAWN
Pharmacokinetics of Antiplatelet Drugs in Diabetic pAtients
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Conditions:
Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 a...
Detailed Description
Clopidogrel efficacy appears diminished in patients with T2D who continue to show an increased risk of adverse cardiovascular events and mortality compared to those without T2D. To the contrary, respo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02302508
Start Date
September 1 2019
End Date
December 1 2021
Last Update
July 24 2019
Active Locations (1)
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1
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X0A9