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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02224274
Date of registration: 19/08/2014
Prospective Registration: No
Primary sponsor: University Medical Centre Ljubljana
Public title: Antiplatelet Therapy After Cardiac Arrest
Scientific title: Comparison of Antiplatelet Therapy With Clopidogrel and Ticagrelor in Patients After Cardiac Arrest Treated With Therapeutic Hypothermia
Date of first enrolment: August 2014
Target sample size: 57
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02224274
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Slovenia
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Female and male over 18 years old

- Unconscious survivors of cardiac arrest treated with therapeutic hypothermia

- Acute coronary syndrome (NSTEMI or STEMI) as a reason of cardiac arrest

- PCI with stent implantation

- Provision of informed consent prior to any study specific procedures is impossible
because subjects are unconscious at the moment of inclusion

Exclusion Criteria:

- Use of any P2Y12 inhibitors in last 10 days

- Use of prasugrel before and 48 hours after loading dose of P2Y12 inhibitor

- Use of eptifibatide before and 48 hours after loading dose of P2Y12 inhibitor

- Thrombocytopenia (<50*109/L)

- Allergic reaction to acetylsalicylic acid, clopidogrel or ticagrelor

- Ticagrelor contraindications: previous intracranial bleeding, active pathological
bleeding, moderate to severe hepatic impairment, heart rate < 40/min at presentation

- Suspected or confirmed pregnancy

- Use of bivalirudin before and 48 hours after loading dose of P2Y12 inhibitor



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Postresuscitation Syndrome
Cardiac Arrest
Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)
Intervention(s)
Drug: Clopidogrel
Drug: Ticagrelor
Primary Outcome(s)
VerifyNow P2Y12Test - Platelet Reactivity [Time Frame: 12 h after P2Y12 inhibitor loading]
Secondary Outcome(s)
VerifyNow P2Y12Test - % Inhibition [Time Frame: 12 hours after P2Y12 inhibitor loading]
Multiplate ADP Test [Time Frame: 12 hours after P2Y12 inhibitor loading]
Secondary ID(s)
Hypothermia: Clopi vs Tica
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 27/02/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02224274
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