Authorised Therapeutic exploratory (Phase II) 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.

Efficacy and Safety of cangrelor on top of anticoagUlation in patients with myocaRdial infarction related cardiogenic shock/cardiac arrest receiVIng VA-ECMO and/or Impella support – a phase 2, single arm, single center trial

EU CTIS ID: 2024-512829-81-00

What this study is testing

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.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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.

You likely can't join if

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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Find trials near you

This trial is registered in the EU. Search recruiting trials near you for 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. - answer a few quick questions and apply in minutes.

Full record on EU CTIS

SponsorOspedale San Raffaele S.r.l.

Target enrollment50

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.