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Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate in STEMI Patients

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)

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02929888
Acronym
ECCLIPSE-STEMI
Enrollment
60
Registered
2016-10-11
Start date
2016-10-31
Completion date
Unknown
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

ST-segment elevacion myocardial infarction, platelets

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).

Interventions

DRUGAspirin
DRUGLysine Acetilsalicilate

Sponsors

Fundacion Investigacion Interhospitalaria Cardiovascular
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Inhibition of platelet aggregation30 minThe primary endpoint of the study, inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min

Secondary

MeasureTime frameDescription
Inhibition of platelet aggregation30 min, 1h, 4h, 24hInhibition of platelet aggregation using different platelet function test (ADP, collagen, VASP)

Countries

Spain

Contacts

Primary ContactDavid Vivas, MD, PhD
dvivas@secardiologia.es0034 913303149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026