Clinical trial • Phase II • Cardiology|Respiratory

ARGATROBAN MONOHYDRATE for Respiratory failure|Heart failure

Phase II trial of ARGATROBAN MONOHYDRATE for Respiratory failure|Heart failure.

Overview

Trial Therapeutic Area
Cardiology|Respiratory
Trial Disease
Respiratory failure|Heart failure
Trial Stage
Phase II
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
11-12-2025
First CTIS Authorization Date
19-03-2026

Trial design

Randomised, open-label, argatroban low dose (ld) - dose not specified; argatroban standard dose (sd) - dose not specified; enoxaparin low dose (ld) - dose not specified; enoxaparin standard dose (sd) - dose not specified-controlled Phase II trial across 2 sites in Czechia.

Randomised
Yes
Open Label
Yes
Comparator
Argatroban low dose (LD) - dose not specified; Argatroban standard dose (SD) - dose not specified; Enoxaparin low dose (LD) - dose not specified; Enoxaparin standard dose (SD) - dose not specified
Target Sample Size
200
Trial Duration For Participant
180

Eligibility

Recruits 200 Vulnerable population selected; informed consent required according to the procedure specified in the protocol. No specific assent procedures or additional vulnerable-population consent details are described in the available documents..

Pregnancy Exclusion
Pregnancy and breastfeeding
Vulnerable Population
Vulnerable population selected; informed consent required according to the procedure specified in the protocol. No specific assent procedures or additional vulnerable-population consent details are described in the available documents.

Inclusion criteria

  • {"criterion_text":"- ECMO support with argatroban / enoxaparin anticoagulation"}
  • {"criterion_text":"- Age ≥ 18 years"}
  • {"criterion_text":"- Obtaining informed consent according to the procedure specified in the protocol"}

Exclusion criteria

  • {"criterion_text":"- Inclusion in the lung transplant program at Motol Hospital"}
  • {"criterion_text":"- Known hypersensitivity to components of the investigational medicinal products"}
  • {"criterion_text":"- Allergic reaction to the active substances of the investigational medicinal products"}
  • {"criterion_text":"- Pregnancy and breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To comprehensively compare the efficacy and safety of anticoagulation therapy in patients on ECMO support with argatroban, enoxaparin and in the combined population of patients with argatroban or enoxaparin","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- To determine the relationship between argatroban concentration and the incidence of bleeding and thrombotic complications and the consumption of blood derivatives and transfusion products","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To determine the relationship between the dose or concentration of anticoagulant and laboratory parameters for monitoring anticoagulation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To determine the relationship between laboratory parameters and bleeding and thrombotic complications","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
200
Recruitment Window Months
23
Consent Approach
Informed consent must be obtained according to the procedure specified in the protocol. Subject information and informed consent form documents are available (L1_ICF_Main+GDPR versions 1.0 and 2.0). Participants are adults (Age ≥ 18 years) and provide consent themselves. No explicit details on assent or the languages of the consent documents are provided in the available data.

Geography

Total Number Of Sites
2
Total Number Of Participants
200

Czechia

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
19-03-2026
Processing Time Days
37
Number Of Sites
2
Number Of Participants
200

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Klinika anesteziologie, resuscitace a intenzivní mediciny FN Motol
Contact Person Name
Jaromír Vajter
Contact Person Email
jaromir.vajter@fnmotol.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Klinika anesteziologie, resuscitace a intenzivní mediciny
Contact Person Name
Filip Burša
Contact Person Email
filip.bursa@fno.cz

Sponsor

Primary sponsor

Full Name
Fakultni Nemocnice Ostrava
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Czechia

Investigational products

Investigational Product Name
Argatra Multidose 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Active Substance
ARGATROBAN MONOHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
Max daily dose 0.05 mg/Kg; Max total dose 1.5 mg/Kg
Investigational Product Name
CLEXANE 10 000 IU (100 mg)/1 ml injekční roztok v předplněné injekční stříkačce
Active Substance
ENOXAPARIN SODIUM
Modality
Other
Routes Of Administration
INTRAVENIOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
Max daily dose 480 IU/Kg; Max total dose 13440 IU/Kg

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