Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Other: blood sample

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 Type: Interventional
• Enrollment (Actual): 640
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hôpitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute coronary syndrome patient; Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines accepting blood samples measuring platelets reactivity	Other: blood sample; Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor	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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between VASP index and MACE	the rate of major cardiovascular events ( MACE )	1 month
Relationship between VASP index and MACE		1 year
Relationship between VASP index and BARC	BARC: bleeding academic research complications	1month
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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: Laurent BONELLO, MD, Assistance Publique Hôpitaux de Marseille

Publications and helpful links

General Publications

• Laine M, Frere C, Cuisset T, Paganelli F, Morange PE, Dignat-George F, Berbis J, Camoin-Jau L, Bonello L. Potential mechanism of acute stent thrombosis with bivalirudin following percutaneous coronary intervention in acute coronary syndromes. Int J Cardiol. 2016 Oct 1;220:496-500. doi: 10.1016/j.ijcard.2016.06.247. Epub 2016 Jun 28.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 2014-A01913-44