Ticagrelor vs. Prasugrel in patients with Clopidogrel low response - ISAR ADAPT-PF

INTRACORONARY STENTING AND ANTITHROMBOTIC REGIMEN: ADJUSTING ANTIPLATELET TREATMENT IN PATIENTS BASED ON PLATELET FUNCTION TESTING - ISAR ADAPT-PF - ISAR ADAPT-PF

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001686-40-DE

Enrollment

Registered

2011-06-06

Start date

2011-09-15

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Effect of Ticagrelor and Prasugrel in patients with insufficient responding to Clopidogrel after coronary intervention (non-inferiority of Ticagrelor vs. Prasugrel) MedDRA version: 17.0 Level: LLT Classification code 10003601 Term: Atherosclerosis System Organ Class: 100000004866

Interventions

Trade Name: Efient Product Name: Efient Pharmaceutical Form: Tablet INN or Proposed INN: PRASUGREL CAS Number: 150322-43-3 Trade Name: Brilique Product Name: Brilique Pharmaceutical Form: Tablet CAS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients after coronary intervention - insufficient inhibition of platelet aggregation after Clopidogrel loading - informed, written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: - age , > 80 years - body weight < 60 kg - surgical intervention < 6 weeks - apoplexy in anamnesis - cardiogenic shock - oral anticoagulation - GPIIb/IIIa antagonists < 10 days or periprocedural - platelet count < 100.000/µl - increased risk for bradycardia - severe liver dysfunction - dialysis-dependent renal insufficiency - simultaneous taking of CYP3A4 inhibitors

Design outcomes

Primary

Measure	Time frame
Main Objective: Ticagrelor is not inferior to Prasugrel with regard to the inhibition of platelet aggregation in patients with insufficient response to Clopidogrel.;Secondary Objective: The objective of this clinical trial is to measure the degree of the inhibition of platelet aggregation by the two active substances Ticagrelor and Prasugrel in patients, who received a coronary stent implantation and show an insufficient responding to Clopidogrel after this intervention. The measurement is done by means of full-blood impedance aggregometry using Multiplate Analyzer.;Primary end point(s): ADP-induced platelet aggregation on 2nd. day after randomization;Timepoint(s) of evaluation of this end point: day 2 after randomization	—

Measure

Time frame

Main Objective: Ticagrelor is not inferior to Prasugrel with regard to the inhibition of platelet aggregation in patients with insufficient response to Clopidogrel.;Secondary Objective: The objective of this clinical trial is to measure the degree of the inhibition of platelet aggregation by the two active substances Ticagrelor and Prasugrel in patients, who received a coronary stent implantation and show an insufficient responding to Clopidogrel after this intervention. The measurement is done by means of full-blood impedance aggregometry using Multiplate Analyzer.;Primary end point(s): ADP-induced platelet aggregation on 2nd. day after randomization;Timepoint(s) of evaluation of this end point: day 2 after randomization

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Secondary

Measure	Time frame
Secondary end point(s): - (1)portion of patients with insufficient inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut-off > 468 AUmin) on the 2nd. day after randomization - (2)portion of patients with exceeding inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut-off < 188 AUmin) on the 2nd. day after randomization - (3)ADP-induced platelet aggregation, point in time: 2 weeks after randomization during Ticagrelor or Prasugrel maintenance therapy;Timepoint(s) of evaluation of this end point: - concerning points (1) and (2): day 2 after randomization - concerning point (3): 2 weeks after randomization	—

Measure

Time frame

Secondary end point(s): - (1)portion of patients with insufficient inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut-off > 468 AU*min) on the 2nd. day after randomization - (2)portion of patients with exceeding inhibition of platelet aggregation in the Ticagrelor or in the Prasugrel group (cut-off < 188 AU*min) on the 2nd. day after randomization - (3)ADP-induced platelet aggregation, point in time: 2 weeks after randomization during Ticagrelor or Prasugrel maintenance therapy;Timepoint(s) of evaluation of this end point: - concerning points (1) and (2): day 2 after randomization - concerning point (3): 2 weeks after randomization

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Countries

Germany, Hungary

Contacts

Public ContactISAResearch Center

ISAResearch Center

merzljak@dhm.mhn.de+498912181534

Outcome results

None listed

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