Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02224274 |
Date of registration:
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19/08/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Antiplatelet Therapy After Cardiac Arrest
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Scientific title:
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Comparison of Antiplatelet Therapy With Clopidogrel and Ticagrelor in Patients After Cardiac Arrest Treated With Therapeutic Hypothermia |
Date of first enrolment:
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August 2014 |
Target sample size:
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57 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02224274 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Slovenia
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Postresuscitation Syndrome
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Cardiac Arrest
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Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)
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Intervention(s)
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Drug: Clopidogrel
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Drug: Ticagrelor
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Primary Outcome(s)
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VerifyNow P2Y12Test - Platelet Reactivity
[Time Frame: 12 h after P2Y12 inhibitor loading]
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Secondary Outcome(s)
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VerifyNow P2Y12Test - % Inhibition
[Time Frame: 12 hours after P2Y12 inhibitor loading]
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Multiplate ADP Test
[Time Frame: 12 hours after P2Y12 inhibitor loading]
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Secondary ID(s)
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Hypothermia: Clopi vs Tica
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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