Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate in STEMI Patients (ECCLIPSE-STEMI)
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Lysine Acetilsalicilate
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring ST-segment elevacion myocardial infarction, platelets
Eligibility Criteria
Inclusion Criteria:
- Aged > 18.
- Patients with ST-segment myocardial infarction.
- Signed written informed consent.
Exclusion Criteria:
- Known allergies to aspirin, clopidogrel, prasugrel or ticagrelor.
- Cardiogenic shock or hemodinamic instability.
- Recent antiplatelet therapy (<14 days).
- Oral anticoagulation with a coumarin derivative.
- Any active bleeding or blood dyscrasia.
- Recent gastrointestinal bleeding (<6 months prior to inclusion).
- Recent history of stroke, TIA or intracranial bleeding (<6 months prior to inclusion).
- Known anemia, trombopenia or severe chronic kidney/liver disease
- Any known active neoplasm.
- Pregnant females.
Sites / Locations
- FundacionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lysine Acetilsalicilate (LA)
Aspirin
Arm Description
Loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction
Loading dose (LD) of oral aspirin 300mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction
Outcomes
Primary Outcome Measures
Inhibition of platelet aggregation
The primary endpoint of the study, inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min
Secondary Outcome Measures
Inhibition of platelet aggregation
Inhibition of platelet aggregation using different platelet function test (ADP, collagen, VASP)
Full Information
NCT ID
NCT02929888
First Posted
October 8, 2016
Last Updated
October 10, 2016
Sponsor
Fundacion Investigacion Interhospitalaria Cardiovascular
1. Study Identification
Unique Protocol Identification Number
NCT02929888
Brief Title
Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate in STEMI Patients
Acronym
ECCLIPSE-STEMI
Official Title
Effects of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Platelet Responsiveness in Patients With ST-segment Elevation Myocardial Infarction: a Pharmacodynamic Study (ECCLIPSE-STEMI Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Investigacion Interhospitalaria Cardiovascular
4. Oversight
5. Study Description
Brief Summary
Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute coronary syndrome. However, evidence is lacked about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to oral aspirin on prasugrel inhibited platelets. Recently, we demonstrated in healthy volunteers that the administration of intravenous LA resulted in a significantly reduction of platelet reactivity compared to oral aspirin on prasugrel inhibited platelets. Loading dose of LA achieves platelet inhibition faster, greater and with less variability than aspirin. However, there are no data of this issue in patients with an ST-segment elevation myocardial infarction (STEMI). The ECCLIPSE-STEMI trial will study the effect of LA versus aspirin in platelet reactivity in patients with STEMI
Detailed Description
This is a prospective, randomized, single-center, open platelet function study conducted in 60 STEMI patients. Subjects were randomly assigned to receive a loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg, or LD of aspirin 300mg plus prasugrel 60mg/ticagrelor 180mg orally. Platelet function was evaluated at baseline, 30 min, 1h, 4h, and 24h using multiple electrode aggregometry and vasodilator-stimulated phosphoprotein phosphorylation (VASP). The primary endpoint of the study is the inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min. Secondary endopoints are the inhibition of platelet aggregation after AA baseline and at 1h, 4h and 24h, and measurement of aggregation with other platelet test (ADP, collagen and VASP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
ST-segment elevacion myocardial infarction, platelets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lysine Acetilsalicilate (LA)
Arm Type
Experimental
Arm Description
Loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Loading dose (LD) of oral aspirin 300mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction
Intervention Type
Drug
Intervention Name(s)
Lysine Acetilsalicilate
Intervention Type
Drug
Intervention Name(s)
Aspirin
Primary Outcome Measure Information:
Title
Inhibition of platelet aggregation
Description
The primary endpoint of the study, inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min
Time Frame
30 min
Secondary Outcome Measure Information:
Title
Inhibition of platelet aggregation
Description
Inhibition of platelet aggregation using different platelet function test (ADP, collagen, VASP)
Time Frame
30 min, 1h, 4h, 24h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged > 18.
Patients with ST-segment myocardial infarction.
Signed written informed consent.
Exclusion Criteria:
Known allergies to aspirin, clopidogrel, prasugrel or ticagrelor.
Cardiogenic shock or hemodinamic instability.
Recent antiplatelet therapy (<14 days).
Oral anticoagulation with a coumarin derivative.
Any active bleeding or blood dyscrasia.
Recent gastrointestinal bleeding (<6 months prior to inclusion).
Recent history of stroke, TIA or intracranial bleeding (<6 months prior to inclusion).
Known anemia, trombopenia or severe chronic kidney/liver disease
Any known active neoplasm.
Pregnant females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Vivas, MD, PhD
Phone
0034 913303149
Ext
3149
Email
dvivas@secardiologia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Vivas, MD, PhD
Organizational Affiliation
San Carlos University Hospital, Madrid, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Vivas, MD, PhD
Phone
0034913303149
Ext
3149
Email
dvivas@secardiologia.es
12. IPD Sharing Statement
Learn more about this trial
Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate in STEMI Patients
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