Overview
Sponsor-declared trial summary
Adult patients treated in VA ECMO/Impella for cardiogenic shock/cardiac arrest undergoing PCI. Given the high incidence of bleeding from conventional antithrombotic therapy, the use of readily available and rapidly metabolized cangrelor should result in adequate efficacy and increased safety. Patients will receive scoagulation with bivalirudin (target apt 55-70 seconds) and cangrelor with starting dose 0.125 mcg/kg/min and adjusted with step +/- 0.125 mcg/kg/min.
Objective of this study is to assess the feasibility, efficacy (prevention of thrombotic events) and safety (minimization of haemorrhagic events) of an antithrombotic therapy combining bivalirudin and cangrelor titrated based on the results of platelet function assay in patients undergoing PCI for ACS during VA-ECMO su…
Key facts
- Sponsor
- Ospedale San Raffaele S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 10 Apr 2024 → ongoing
- Decision date (initial)
- 2024-05-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512829-81-00
- EudraCT number
- 2022-003199-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Objective of this study is to assess the feasibility, efficacy (prevention of thrombotic events) and safety (minimization of haemorrhagic events) of an antithrombotic therapy combining bivalirudin and cangrelor titrated based on the results of platelet function assay in patients undergoing PCI for ACS during VA-ECMO support for CS/CA.
Conditions and MedDRA coding
Adult patients treated in VA ECMO/Impella for cardiogenic shock/cardiac arrest undergoing PCI. Given the high incidence of bleeding from conventional antithrombotic therapy, the use of readily available and rapidly metabolized cangrelor should result in adequate efficacy and increased safety. Patients will receive scoagulation with bivalirudin (target apt 55-70 seconds) and cangrelor with starting dose 0.125 mcg/kg/min and adjusted with step +/- 0.125 mcg/kg/min.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10040563 | Shock cardiogenic | 10007541 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male or female patients aged >=18 years
- ACS-related CS/CA patients undergoing PCI (either with or without stent implantation) and needing tMCS withVA-ECMO/Impella support
- Patients who received pre-hospital aspirin i.v. loading dose or patients naïve to any anti-thrombotic agent.
- 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 6
- Overt uncontrollable bleeding
- Suspected intra-cranial haemorrhage
- Patients who received any dose of any oral P2Y12-inhibitors
- Patients with known history of stroke or Transient Ischaemic Attack (TIA);
- Patients with known hypersensitivity to the active substance (cangrelor) or to any of its excipients.
- Pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 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).
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Kengrexal 50 mg powder for concentrate for solution for injection/infusion
PRD4355294 · Product
- Active substance
- Cangrelor Tetrasodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0.75 µg/Kg microgram(s)/kilogram
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC25 — -
- Marketing authorisation
- EU/1/15/994/001
- MA holder
- CHIESI FARMACEUTICI S.P.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Mara Scandroglio
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Mara Scandroglio
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-04-10 | 2024-04-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512829-81-00_Redacted | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Adult patients_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Legal guardian_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_ICF Privacy Statement_Redacted | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Kengrexal | 1 |
| Synopsis of the protocol (for publication) | D2_Protocol synopsis_IT_Redacted | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-02 | Italy | Acceptable 2024-04-26
|
2024-05-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-26 | Italy | Acceptable 2024-12-02
|
2024-12-06 |