Testing the responsiveness of patients admitted to intensive care units to treatment with anti-platelet drugs (acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor)

High “on treatment” platelet reactivity in the Intensive Care Unit - HTPR-ICU

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002226-76-AT

Enrollment

262

Registered

2012-10-03

Start date

2012-11-13

Completion date

Unknown

Last updated

2021-08-24

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

Conditions

mixed medical intensive care unit patients MedDRA version: 20.0 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Aspirin i.v. Product Name: Aspirin i.v. Product Code: Aspirin i.v. Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: DL Lysinacetylsalicylat Glycin CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: =18years of age Admittance to an ICU pretreatment with Acetylsalicylic acid, clopidogrel, prasugrel or pantoprazole ex-vivo study: Acute Myocardial infarction ex vivo study(2): =18years of age Admittance to an ICU pretreatment with clopidogrel, prasugrel or ticagrelor 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 148 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Recent surgery Active bleeding Known coagulation disorders Discretion of the physician Terminal illness (anticipated life expectancy <3months; e.g. due to cancer) ex-vivo study: thrombocytopenia ex-vivo study(2): thrombocytopenia

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine whether high "on treatment" platelet reactivity (HTPR) in acetylsalicylic-acid treated patients can be overcome by using intravenous ASA or crushed chewable ASA tablets or dose increase; To examine the pharmacodynamic response of prasugrel or ticagrelor in patients with HTPR to clopidogrel; To investigate whether cangrelor achieves sufficient inhibition of ADP-induced platelet aggregation in ICU patients with HTPR in an ex vivo spiking model/APD-induced platelet aggregation tested with multiple electrode aggregometry between groups.;Secondary Objective: To evaluate the pharmacokinetic profile of ASA, clopidogrel, prasugrel and ticagrelor in ICU patients; To compare the PK and PD of hemodynamically instable patients with stable patients; To evaluate the function of the cytochrome system by evaluating the PK of pantoprazole To evaluate the platelet-inhibitory effects of cangrelor on platelets of ICU patients ex vivo. To evaluate the platelet-inhibitory effects of cangrelor on platelets with VASP-P assay and VerifyNow analysis ex vivo. To investigate whether cangrelor can be titrated to a certain level of platelet inhibition and can be measured by MEA analysis.;Primary end point(s): arachidonic acid induced aggregation tested with the multiplate electrode aggregometry (MEA, Multiplate) of patients with HTPR to ASA after receiving either 100mg intravenous ASA, 200mg of ASA crushed regular tablets or crushed chewable 81mg ASA tablets. ADP induced aggregation tested with MEA of patients with HTPR to clopidogrel ADP induced aggregation tested with MEA of patients with HTPR to prasugrel ex-vivo: ADP-induced whole blood aggregometry ex-vivo(2): ADP-induced whole blood aggregometry;Timepoint(s) of evaluation of this end point: first part: all patients tested for high on treatment platelet reactivity before study drug intake and 2 and 24 hours therafter interventional trial: before administration of the study drug and 1-2-4-24 hours thereafte	—

Measure

Time frame

Main Objective: To examine whether high "on treatment" platelet reactivity (HTPR) in acetylsalicylic-acid treated patients can be overcome by using intravenous ASA or crushed chewable ASA tablets or dose increase; To examine the pharmacodynamic response of prasugrel or ticagrelor in patients with HTPR to clopidogrel; To investigate whether cangrelor achieves sufficient inhibition of ADP-induced platelet aggregation in ICU patients with HTPR in an ex vivo spiking model/APD-induced platelet aggregation tested with multiple electrode aggregometry between groups.;Secondary Objective: To evaluate the pharmacokinetic profile of ASA, clopidogrel, prasugrel and ticagrelor in ICU patients; To compare the PK and PD of hemodynamically instable patients with stable patients; To evaluate the function of the cytochrome system by evaluating the PK of pantoprazole To evaluate the platelet-inhibitory effects of cangrelor on platelets of ICU patients ex vivo. To evaluate the platelet-inhibitory effects of cangrelor on platelets with VASP-P assay and VerifyNow analysis ex vivo. To investigate whether cangrelor can be titrated to a certain level of platelet inhibition and can be measured by MEA analysis.;Primary end point(s): arachidonic acid induced aggregation tested with the multiplate electrode aggregometry (MEA, Multiplate) of patients with HTPR to ASA after receiving either 100mg intravenous ASA, 200mg of ASA crushed regular tablets or crushed chewable 81mg ASA tablets. ADP induced aggregation tested with MEA of patients with HTPR to clopidogrel ADP induced aggregation tested with MEA of patients with HTPR to prasugrel ex-vivo: ADP-induced whole blood aggregometry ex-vivo(2): ADP-induced whole blood aggregometry;Timepoint(s) of evaluation of this end point: first part: all patients tested for high on treatment platelet reactivity before study drug intake and 2 and 24 hours therafter interventional trial: before administration of the study drug and 1-2-4-24 hours thereafte

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Secondary

Measure	Time frame
Secondary end point(s): Prevalence of HTPR in the ICU Evaluation of the PK profile Development of HTPR during ICU stay Comparison of hemodynamically stable with unstable patients (unstable: serum lactate values =2.2 mmol/l, need for circulatory support) ICU mortality Major bleeding ex-vivo: - ADP+PGE induced platelet aggregation, - Platelet function under high shear rates using ADP and P2Y12 cartridges - VASP-Assay ex-vivo(2): - VASP-P assay - VerifyNow analysis - correlation of VASP-P assay and ADP-induced platelet aggregation;Timepoint(s) of evaluation of this end point: PK: first part: all patients tested for high on treatment platelet reactivity before study drug intake and 2 and 24 hours therafter interventional trial: before administration of the study drug and 1-2-4-24 hours thereafter In some patients: PK evaluation at 0, 15, 30, 45, 60, 90 minutes and 2, 4, 6 and 24 hours after intake of 75mg clopidogrel or pantoprazole. all other secondary endpoints continuously during the ICU stay ex-vivo: single time point assessments ex-vivo(2): single time point assessments	—

Measure

Time frame

Secondary end point(s): Prevalence of HTPR in the ICU Evaluation of the PK profile Development of HTPR during ICU stay Comparison of hemodynamically stable with unstable patients (unstable: serum lactate values =2.2 mmol/l, need for circulatory support) ICU mortality Major bleeding ex-vivo: - ADP+PGE induced platelet aggregation, - Platelet function under high shear rates using ADP and P2Y12 cartridges - VASP-Assay ex-vivo(2): - VASP-P assay - VerifyNow analysis - correlation of VASP-P assay and ADP-induced platelet aggregation;Timepoint(s) of evaluation of this end point: PK: first part: all patients tested for high on treatment platelet reactivity before study drug intake and 2 and 24 hours therafter interventional trial: before administration of the study drug and 1-2-4-24 hours thereafter In some patients: PK evaluation at 0, 15, 30, 45, 60, 90 minutes and 2, 4, 6 and 24 hours after intake of 75mg clopidogrel or pantoprazole. all other secondary endpoints continuously during the ICU stay ex-vivo: single time point assessments ex-vivo(2): single time point assessments

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Countries

Austria

Contacts

Public ContactDepartment of Clinical Pharmacology

Medical University of Vienna

klin-pharmakologie@meduniwien.ac.at004301404002981

Outcome results

None listed

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