Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Other: blood sample

• Registration Number: NCT02428725
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-03-26
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-29
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-06
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute coronary syndrome patient	blood sample	Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines accepting blood samples measuring platelets reactivity

Primary Outcome Measures

Name	Time	Method
Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor	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 Outcome Measures

Name	Time	Method
Relationship between VASP index and MACE	1 year
Relationship between VASP index and BARC	1month	BARC: bleeding academic research complications
Compliance to ticagrelor	1 year
Evaluate Adenosine deaminase	1 year
evaluate DDP IV activity	1 year
Evaluate microparticules number and activity under ticagrelor	1 year

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France