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Antiplatelet Therapy After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT02224274
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Marko Noc, University Medical Centre Ljubljana

Brief Summary:

There is growing evidence that standard dual antiplatelet therapy with acetylsalicylic acid (ASA) and clopidogrel is not as effective in the setting of therapeutic hypothermia after cardiac arrest as in normothermic patients. The reasons for this are probably slower gastrointestinal motility, absorption and liver metabolism required for clopidogrel to take action. Since ticagrelor has faster intestinal absorption and no need for liver metabolism we expect its effect to be good even in patients with therapeutic hypothermia after cardiac arrest. Patients treated with therapeutic hypothermia after cardiac arrest and percutaneous coronary intervention will be randomised into two groups. One will be treated with ASA and clopidogrel and the other with ASA and ticagrelor. Blood samples will be collected before and 2, 4, 12, 22 and 48 hours after P2Y12 inhibitor administration. Platelet function will be measured by VerifyNow P2Y12 assay and by Multiplate ADPTest. Differences between the groups will be analysed.

Hypothesis: Antiplatelet therapy with ticagrelor is more effective than therapy with clopidogrel in the comatose survivors of cardiac arrest treated with therapeutic hypothermia and percutaneous coronary intervention (PCI).


Condition or disease Intervention/treatment Phase
Cardiac Arrest Postresuscitation Syndrome Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction) Drug: Clopidogrel Drug: Ticagrelor Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Antiplatelet Therapy With Clopidogrel and Ticagrelor in Patients After Cardiac Arrest Treated With Therapeutic Hypothermia
Study Start Date : August 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clopidogrel
These patients will be treated with clopidogrel 600 mg loading and than 75 mg/24 h.
Drug: Clopidogrel
Other Name: Clopidogrel (Plavix)

Experimental: Ticagrelor
These patients will be treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Drug: Ticagrelor
Other Name: Ticagrelor (Brilique)




Primary Outcome Measures :
  1. VerifyNow P2Y12Test - Platelet Reactivity [ Time Frame: 12 h after P2Y12 inhibitor loading ]
    Platelet reactivity reflects P2Y12 inhibitor effect. Higher values mean normal platelet reactivity due to low P2Y12 inhibition response, while lower values mean decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.


Secondary Outcome Measures :
  1. VerifyNow P2Y12Test - % Inhibition [ Time Frame: 12 hours after P2Y12 inhibitor loading ]
    % inhibition reflects P2Y12 inhibitor effect regarding basal platelet reactivity (defined as: (1- (platelet reactivity/basal platelet reactivity)) x 100). Higher values mean better P2Y12 inhibition response. High on-treatment platelet reactivity was defined as <11% inhibition.

  2. Multiplate ADP Test [ Time Frame: 12 hours after P2Y12 inhibitor loading ]

    Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets.

    High on-treatment platelet reactivity was defined as >46 U.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224274


Locations
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Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana

Publications:

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Responsible Party: Marko Noc, Marko Noc, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02224274     History of Changes
Other Study ID Numbers: Hypothermia: Clopi vs Tica
First Posted: August 25, 2014    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019
Last Verified: October 2018

Keywords provided by Marko Noc, University Medical Centre Ljubljana:
Antiplatelet Therapy
Cardiac Arrest
Therapeutic hypothermia
Myocardial infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Heart Arrest
ST Elevation Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs