Antiplatelet Therapy After Cardiac Arrest

October 17, 2018 updated by: Marko Noc, University Medical Centre Ljubljana

Comparison of Antiplatelet Therapy With Clopidogrel and Ticagrelor in Patients After Cardiac Arrest Treated With Therapeutic Hypothermia

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Clopidogrel (Plavix)
Experimental: Ticagrelor
These patients will be treated with ticagrelor 180 mg loading and than 90 mg/12 h.
Drug: Ticagrelor
Other Names:
  • Ticagrelor (Brilique)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 h after P2Y12 inhibitor loading

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 hours after P2Y12 inhibitor loading
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.
12 hours after P2Y12 inhibitor loading

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hypothermia: Clopi vs Tica

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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