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Completed

NCT Number: NCT02428725

Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome

This study will try to determine if the measure of the platelet reactivity of the patients receiving from the ticagrelor continuation in an acute coronary syndrome handled by coronary angioplasty allows to predict the hemorrhagic risk.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

About this study

The use of thienopyridines in patients undergoing percutaneous coronary intervention (PCI) has dramatically decreased the rate of early stent thrombosis. Further the CURE trial demonstrated that long-term clopidogrel decreases the rate of major adverse cardiovascular events in acute coronary syndrome patients (ACS) . However clopidogrel has several limitations including a long delay of action which is a potential limitation in acute settings of coronary artery disease. Another major limitation of the drug is the wide inter individual variability in clopidogrel responsiveness related to various factors.

In addition recent studies suggested that platelet reactivity inhibition does also determine the bleeding risk.

The ticagrelor is a new blocker of the receiver P2Y12 which distinguishes itself from the clopidogrel by a superior biological efficiency. This biological property was translated in the study PLATO, having compared it with the clopidogrel in the ACS, by a reduction of the risk thrombotique. The ticagrelor is thus recommended in first intention in this indication. There seems be a variability of answer to the ticagrelor. Besides the ticagrelor infers a level of intense platelet inhibition which could explain on hemorrhagic risk which is associated with it.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines.

Exclusion criteria

  • New York Heart Association functional class III or IV
  • Cardiac arrest
  • Contra-indications to antiplatelet therapy
  • Platelet count <100 G/l
  • History of bleeding diathesis
  • Concurrent severe illness with expected survival of < 1 year month
  • Pregnant of childbearing woman
  • Inability to provide an informed consent
  • Contra indication to ticagrelor.

Treatment and study plan

blood sample

Other

Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor

Primary outcomes

  1. Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor

    Time frame: one year

    Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose is associated with the occurrence of BARC bleedings ≥ 2 at one year post-PCI.

Secondary outcomes

  1. Relationship between VASP index and MACE

    Time frame: 1 month

    the rate of major cardiovascular events ( MACE )

  2. Relationship between VASP index and MACE

    Time frame: 1 year

  3. Relationship between VASP index and BARC

    Time frame: 1month

    BARC: bleeding academic research complications

  4. Compliance to ticagrelor

    Time frame: 1 year

  5. Evaluate Adenosine deaminase

    Time frame: 1 year

  6. evaluate DDP IV activity

    Time frame: 1 year

  7. Evaluate microparticules number and activity under ticagrelor

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2015
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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