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

NCT02323971 | Unknown DMC

• 1 other identifier: FFI-TIC-2014-01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• platelet reactivity units

  The primary endpoint is the comparison of the platelet reactivity units (PRU) values determined by VerfifyNow-P2Y12 system between normal renal function and CKD patients after 7±2 days of concomitant treatment with ticagrelor.

  7+2 days of treatment

Secondary Outcomes (3)

• platelet reactivity profiles after loading dose of ticagrelor

  30 min, 1, 2, 4 and 6 hours

• platelet reactivity profiles after 180 mg loading dose to ticagrelor usin MEA

  30 min, 1, 2, 4 and 6 hours

• ticagrelor active metabolite levels

  30 min, 1, 2, 4 and 6 hours

Interventions

Ticagrelor DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with CKD and with normal renal function

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Hospital Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Tello-Montoliu MD Antonio

  Hospital Universitario Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tello-Montoliu MD Antonio

CONTACT

atellomont@hotmail.com

Tello-Montoliu MD Antonio

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 24, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 14, 2017

Record last verified: 2017-12

Locations

ES (1)