COMPARISON OF SWITCHING PRASUGREL OR TICAGRELOR IN ELDERLY PATIENTS WITH CORONARY ARTERY DISEASE

Phase 1

Conditions: CORONARY ARTERY DISEASE
MedDRA version: 16.1Level: HLGTClassification code 10011082Term: Coronary artery disordersSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-000472-16-ES

Lead Sponsor: Fundación Interhospitalaria para la Investigación Cardiovascular

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age ? 75 years.
Angiographically documented Coronary Artery Disease.
Chronic treatment (? 1 month) with dual antiplatelet therapy: aspirin (100mg/day) and clopidogrel (75mg/day).
High platelet reactivity Informed consent appropriately signed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Known allergies to aspirin, clopidogrel, prasugrel, or ticagrelor.
Blood dyscrasia or bleeding diathesis.
Recent acute coronary syndrome (< 30 days) or hemodinamic instability.
Recent antiplatelet therapy (< 14 days), with the exception of aspirin and clopidogrel, including: cilostazol, dipiridamol, glycoprotein IIb/IIIa inhibitors.
Concomitant oral anticoagulation.
Any active bleeding.
History of stroke, ischemic transient attack or intracranial bleeding.
Platelet count < 100,000 / ?L.
Any active neoplasm.
Severe chronic kidney disease (creatinine clearance measured with Cockroft-Gault formula < 30mL/min).
Baseline ALT > 2.5 times the upper limit of normality.
Participation in another study involving the administration of an investigational product in the past 4 months.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the degree of inhibition of platelet aggregation (IPA) after administration of prasugrel versus ticagrelor at 1 week on treatment.;Secondary Objective: To compare the degree of inhibition of platelet aggregation (IPA) at 0 (baseline), and 24 hours after the administration of both treatment groups. <br>To compare the degree of inhibition of platelet reactivity (IRP) throughout the time period in both treatment groups.<br>To evaluate the safety of the treatment administered.;Primary end point(s): Inhibition of platelet aggregation (IPA) by light transmission aggregometry at one week after administration of study drugs;Timepoint(s) of evaluation of this end point: screening, baseline, 24 hours and one week

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): IAP by light transmission aggregometry at baseline and 24 hours after administration of study medication.<br>Inhibition of platelet reactivity (IRP) throughout the sequence.<br>Incidence of adverse events.;Timepoint(s) of evaluation of this end point: screening, baseline, 24 hours and one week