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Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute coronary syndrome patient

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Relationship between VASP index and MACE
the rate of major cardiovascular events ( MACE )
Relationship between VASP index and MACE
Relationship between VASP index and BARC
BARC: bleeding academic research complications
Compliance to ticagrelor
Evaluate Adenosine deaminase
evaluate DDP IV activity
Evaluate microparticules number and activity under ticagrelor

Full Information

First Posted
March 26, 2015
Last Updated
April 6, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02428725
Brief Title
Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome
Official Title
Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome in Patients Undergoing Percutaneous Coronary Intervention for an Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acute coronary syndrome patient
Arm Type
Experimental
Arm Description
Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines accepting blood samples measuring platelets reactivity
Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
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 Outcome Measure Information:
Title
Platelet reactivity inhibition measured by the VASP index 6 to 12 hours after the loading dose of ticagrelor
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Relationship between VASP index and MACE
Description
the rate of major cardiovascular events ( MACE )
Time Frame
1 month
Title
Relationship between VASP index and MACE
Time Frame
1 year
Title
Relationship between VASP index and BARC
Description
BARC: bleeding academic research complications
Time Frame
1month
Title
Compliance to ticagrelor
Time Frame
1 year
Title
Evaluate Adenosine deaminase
Time Frame
1 year
Title
evaluate DDP IV activity
Time Frame
1 year
Title
Evaluate microparticules number and activity under ticagrelor
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent BONELLO, MD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27390976
Citation
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.
Results Reference
derived

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Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome

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