Effect of an additional therapy with the blood thinner cangrelor compared to the standard therapy in patients with heart attack caused by myocardial infarctio

Phase 1

• Conditions: ST-elevation myocardial infarction, cardiac arrest; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003265-26-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-24
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Age 18-74 years
•Comatose survivors of OHCA
•Estimated 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)
•Initial shockable rhythm (i.e. ventricular fibrillation or pulseless ventricular tachycardia)
•Application of TTM (32–34°C target temperature)
•Diagnosis of ST elevation myocardial infarction (post-ROSC electrocardiography)
•Scheduled for PCI
•Eligible for treatment with standard loading doses of DAPT including acetylsalicylic acid and either prasugrel or ticagrelor

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified