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 range
18 Years – 74 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Platelet reactivity at stent placement
Timeframe: up to 4 hours; time from study drug administration (Cangrelor/Placebo) to stent placement