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

COMPARISON OF SWITCHING PRASUGREL OR TICAGRELOR IN ELDERLY PATIENTS WITH CORONARY ARTERY DISEASE ON CLOPIDOGREL THERAPY WITH HIGH PLATELET REACTIVITY: A RANDOMIZED PHARMACODYNAMIC STUDY - PRATICEL STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000472-16-ES

Enrollment

Unknown

Registered

2014-01-16

Start date

2014-02-20

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CORONARY ARTERY DISEASE MedDRA version: 16.1 Level: HLGT Classification code 10011082 Term: Coronary artery disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: efient 5 mg Pharmaceutical Form: Tablet Trade Name: BRILIQUE 90 mg Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Known allergies to aspirin, clopidogrel, prasugrel, or ticagrelor. Blood dyscrasia or bleeding diathesis. Recent acute coronary syndrome ( 2.5 times the upper limit of normality. Participation in another study involving the administration of an investigational product in the past 4 months.

Design outcomes

Primary

Measure	Time frame
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. To compare the degree of inhibition of platelet reactivity (IRP) throughout the time period in both treatment groups. 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	—

Measure

Time frame

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. To compare the degree of inhibition of platelet reactivity (IRP) throughout the time period in both treatment groups. 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

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

Countries

Spain

Contacts

Public ContactUCICEC

Fundación para la Investigación Biomédica Hospital Clínico San Carlos

fibucicec.hcsc@salud.madrid.org349133030003793

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026