Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428725
• Other study ID #: 2014-A01913-44
• Status: Completed
• Phase: N/A
• First received: March 26, 2015
• Last updated: April 6, 2018
• Start date: April 2015
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 640
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relationship between VASP index and MACE	the rate of major cardiovascular events ( MACE )	1 month
Secondary	Relationship between VASP index and MACE		1 year
Secondary	Relationship between VASP index and BARC	BARC: bleeding academic research complications	1month
Secondary	Compliance to ticagrelor		1 year
Secondary	Evaluate Adenosine deaminase		1 year
Secondary	evaluate DDP IV activity		1 year
Secondary	Evaluate microparticules number and activity under ticagrelor		1 year