UnknownPhase 4

Add-on Cangrelor in STEMI-triggered Cardiac Arrest

Austria60 participantsStarted 2017-09

Plain-language summary

In patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary angioplasty (PCI) P2Y12 receptor (P2Y12r) inhibition should be achieved as soon as possible. Resuscitated STEMI-patients receiving targeted temperature management (TTM, therapeutic hypothermia) after cardiac arrest, however, show deteriorated and delayed early response to available oral P2Y12r inhibitors. Therapeutic hypothermia attenuates the drugs' effectiveness by reducing its gastrointestinal absorption and metabolic activation. Acute stent thrombosis is 5-fold increased after angioplasty following resuscitated cardiac arrest because of insufficient early platelet suppression. Thus, aggressive antiplatelet strategies are needed to achieve optimal platelet suppression during PCI in those patients. The first intravenous P2Y12r inhibitor, cangrelor, has recently received marketing authorization for the acute treatment of STEMI. We hypothesize that add-on antiplatelet therapy with intravenous Cangrelor on-top of standard dual anti platelet therapy (DAPT) with Prasugrel or Ticagrelor is superior to standard antiplatelet therapy alone in terms of suppressing ADP-dependent platelet activation in resuscitated STEMI-patients receiving TTM.

Who can participate

Age range18 Years – 74 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-74 years * comatose survivors of OHCA * initial shockable rhythm (i.e. ventricular fibrillation or pulseless ventricular tachycardia) * STEMI (post-ROSC electrocardiography) * application of TTM; * scheduled for PCI * interval of \<10 min from cardiac arrest to initiation of cardiopulmonary * resuscitation (no-flow interval); interval of \<60 min from initiation of cardiopulmonary resuscitation * to ROSC (low-flow interval) * eligible for treatment with standard loading doses of DAPT including * aspirin and either prasugrel or ticagrelor. Exclusion Criteria: * Pregnant or breast-feeding patients * Body weight \<60kg * Response to verbal commands after ROSC * (thus not eligible for TTM) * Cardiac arrest due to: trauma, exsanguination, strangulation, smoke * inhalation, drug overdose, electrocution, hanging or drowning, or intracranial hemorrhage * Patients not * achieving ROSC or subjected to an extracorporeal circulatory assist device * Acute treatment with P2Y12r inhibitor other than prasugrel or ticagrelor * Active bleeding or increased risk of bleeding because of irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled * severe hypertension * Known history of ischemic or hemorrhagic stroke or transient ischemic attack * (TIA) * Known history of severe hepatic impairment (Child Pugh C) * Known history of severe renal impairment (creatinine clearance \<30mL/min) * Hypersensitivity to the active substance or to a…

What they're measuring

Platelet reactivity at stent placement

Timeframe: up to 4 hours; time from study drug administration (Cangrelor/Placebo) to stent placement

Trial details

NCT IDNCT03273075

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05

Contact for this trial

Alexander O. Spiel, Prof., MD

+4314040039530 alexander.spiel@meduinwien.ac.at