Clinical trial • Phase II • Cardiology

CANGRELOR TETRASODIUM for Cardiogenic shock | Cardiac arrest | Acute myocardial infarction

Phase II trial of CANGRELOR TETRASODIUM for Cardiogenic shock | Cardiac arrest | Acute myocardial infarction. open-label, adaptive. 50 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Cardiogenic shock | Cardiac arrest | Acute myocardial infarction
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
02-04-2024
First CTIS Authorization Date
02-05-2024

Trial design

open-label, adaptive Phase II trial across 1 site in Italy.

Open Label
Yes
Adaptive
True, dose titration rules: cangrelor starting dose 0.125 mcg/kg/min adjusted with step +/- 0.125 mcg/kg/min based on platelet function assay
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
50
Trial Duration For Participant
3

Eligibility

Recruits 50 Written informed consent provided directly by the patient (if conscious) or the patient's legal representative (if unconscious). For patients who do not have a legal representative, the decision may be made by a panel of three doctors..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
Written informed consent provided directly by the patient (if conscious) or the patient's legal representative (if unconscious). For patients who do not have a legal representative, the decision may be made by a panel of three doctors.

Inclusion criteria

  • {"criterion_text":"- Male or female patients aged >=18 years\n- ACS-related CS/CA patients undergoing PCI (either with or without stent implantation) and needing tMCS withVA-ECMO/Impella support\n- Patients who received pre-hospital aspirin i.v. loading dose or patients naïve to any anti-thrombotic agent.\n- Written informed consent provided directly by the patient (if conscious) or the patient's legal representative (if unconscious). For patients who do not have a legal representative, the decision may be made by a panel of three doctors."}

Exclusion criteria

  • {"criterion_text":"- Overt uncontrollable bleeding\n- Suspected intra-cranial haemorrhage\n- Patients who received any dose of any oral P2Y12-inhibitors\n- Patients with known history of stroke or Transient Ischaemic Attack (TIA);\n- Patients with known hypersensitivity to the active substance (cangrelor) or to any of its excipients.\n- Pregnancy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Efficacy and safety clinical endpoint will be the occurrence of thrombotic adverse events and bleeding adverse events, respectively, during the time of cangrelor infusion (see text for adverse events definition).","definition_or_measurement_approach":"Occurrence of thrombotic adverse events and bleeding adverse events during the time of cangrelor infusion; see trial text for adverse events definitions."}
  • {"endpoint_text":"- Safety primary endpoint will be the occurrence of major bleeding events. Major bleeding will be defined as: type 3b or 5 Bleeding Academic Research Consortium (BARC) bleeding.","definition_or_measurement_approach":"Major bleeding defined as BARC type 3b or 5 bleeding."}

Recruitment

Planned Sample Size
50
Recruitment Window Months
36
Consent Approach
Written informed consent provided directly by the patient (if conscious) or the patient's legal representative (if unconscious). For patients who do not have a legal representative, the decision may be made by a panel of three doctors. Subject information and informed consent forms available (documents: L1_ICF Adult patients_Redacted; L1_ICF Legal guardian_Redacted) and a privacy statement (L2_ICF Privacy Statement_Redacted).

Geography

Total Number Of Sites
1
Total Number Of Participants
50

Italy

Earliest CTIS Part Ii Submission Date
14-03-2024
Latest Decision Or Authorization Date
06-12-2024
Processing Time Days
267
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Cardiac surgery and Cardiology Intensive Care Unit Area
Principal Investigator Name
Mara Scandroglio
Principal Investigator Email
scandroglio.mara@hsr.it
Contact Person Name
Mara Scandroglio
Contact Person Email
scandroglio.mara@hsr.it
Number Of Participants
50

Sponsor

Primary sponsor

Full Name
Ospedale San Raffaele S.r.l.
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Investigational products

Investigational Product Name
Kengrexal 50 mg powder for concentrate for solution for injection/infusion
Active Substance
CANGRELOR TETRASODIUM
Modality
Small molecule
Routes Of Administration
Intravenous
Route
Intravenous
Authorisation Status
Authorised (EU marketing authorisation EU/1/15/994/001)
Starting Dose
0.125 mcg/kg/min
Dose Levels
Starting 0.125 mcg/kg/min; dose adjusted in steps +/- 0.125 mcg/kg/min
Frequency
Continuous infusion during VA-ECMO/Impella support
Maximum Dose
100 mg (product maxTotalDoseAmount)
Dose Escalation Increase
Initial 0.125 mcg/kg/min; adjusted in steps of +/- 0.125 mcg/kg/min
Combination Treatment
Yes

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