Status:
UNKNOWN
Add-on Cangrelor in STEMI-triggered Cardiac Arrest
Lead Sponsor:
Medical University of Vienna
Conditions:
Cardiopulmonary Arrest With Successful Resuscitation
ACS - Acute Coronary Syndrome
Eligibility:
All Genders
18-74 years
Phase:
PHASE4
Brief 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 S...
Detailed Description
Neurologic damage after cardiac arrest is frequent and therapeutic options to improve neurological outcome are limited. Treatment by therapeutic hypothermia (TH, 32-34◦C) for 12-24 h showed improved n...
Eligibility Criteria
Inclusion
- 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
- 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 any of the excipients
- Terminal illness present before cardiac arrest
- Thrombolysis therapy
- Scheduled for coronary bypass surgery (CABG)
- Prior P2Y12r inhibitor use in the past 7 days
- Prior vitamin K antagonists/NOACs use in past 7 days
- Patients with known allergic reaction to P2Y12r inhibitors.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03273075
Start Date
September 1 2017
End Date
December 1 2021
Last Update
September 13 2017
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria