Impact of Renal Function on Ticagrelor-Induced Antiplatelet Effects in Coronary Artery Disease Patients

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease (CAD), showing a reduction in adverse events.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Treatments: Ticagrelor

Criteria

Inclusion Criteria:

• Patients presenting with moderate-high risk non-STEACS defined according the current guidelines

• Patients received a loading dose or under chronic treatment with aspirin (100 mg per day) as per standard of care

• Age between 18 and 80 years old

• BMI between 18 and 35 kg/m2

• Provide written informed consent prior to any study specific procedures

Exclusion Criteria:

• History of hemorrhagic stroke or intracranial bleeding

• Known allergies to aspirin, ticagrelor, or clopidogrel

• On treatment with oral anticoagulation (Coumarin derivate, dabigatran, rivaroxaban, apixaban)

• Hemoglobin <10 gm/dL

• Platelet count <80x106/mL

• Blood dyscrasias, active bleeding or hemodynamic instability.

• Patients on hemodialysis or peritoneal dialysis, a change in estimated glomerular filtration rate (eGFR) greater than 15 mL/min within 90 days prior to enrollment, or estimated glomerular filtration rate (eGFR) lower than 15 mL/min/1.73m2

• Patients with known infectious diseases or neoplasia

• Baseline ALT >2.5 times the upper limit of normal

• Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection

• Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel):

fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid). Since omeprazole is the most used proton-pump inhibitor in our clinical environment, we will keep the same prescription rate in both groups to avoid differences results from this described interaction

• Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor):

Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin

• Pregnant females