Platelet Reactivity Inhibition Following Ticagrelor Loading Dose and One Year Outcome
1 other identifier
interventional
640
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 9, 2018
April 1, 2018
3 years
March 26, 2015
April 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Relationship between VASP index and MACE
1 month
Relationship between VASP index and MACE
1 year
Relationship between VASP index and BARC
1month
Compliance to ticagrelor
1 year
Evaluate Adenosine deaminase
1 year
- +2 more secondary outcomes
Study Arms (1)
Acute coronary syndrome patient
EXPERIMENTALAcute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines accepting blood samples measuring platelets reactivity
Interventions
Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor
Eligibility Criteria
You may qualify if:
- Acute coronary syndrome patient undergoing PCI and eligible for ticagrelor therapy according to the guidelines.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Related Publications (1)
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.
PMID: 27390976DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent BONELLO, MD
Assistance Publique Hopitaux De Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
April 29, 2015
Study Start
April 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 9, 2018
Record last verified: 2018-04