NCT02929888

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

October 8, 2016

Last Update Submit

October 10, 2016

Conditions

Acute Myocardial Infarction

Keywords

ST-segment elevacion myocardial infarction, platelets

Outcome Measures

Primary Outcomes (1)

  • Inhibition of platelet aggregation

    The primary endpoint of the study, inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min

    30 min

Secondary Outcomes (1)

  • Inhibition of platelet aggregation

    30 min, 1h, 4h, 24h

Study Arms (2)

Lysine Acetilsalicilate (LA)

EXPERIMENTAL

Loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction

Drug: Lysine Acetilsalicilate

Aspirin

ACTIVE COMPARATOR

Loading dose (LD) of oral aspirin 300mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction

Drug: Aspirin

Interventions

Lysine AcetilsalicilateDRUG
Lysine Acetilsalicilate (LA)
AspirinDRUG
Aspirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged \> 18.
  • Patients with ST-segment myocardial infarction.
  • Signed written informed consent.

You may not qualify if:

  • 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.
  • Known anemia, trombopenia or severe chronic kidney/liver disease
  • Any known active neoplasm.
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (1)

  • Vivas D, Jimenez JJ, Martin-Asenjo R, Bernardo E, Ortega-Pozzi MA, Gomez-Polo JC, Moreno G, Vilacosta I, Perez-Villacastin J, Fernandez-Ortiz A. Effects of intravenous lysine acetylsalicylate versus oral aspirin on platelet responsiveness in patients with ST-segment elevation myocardial infarction: the ECCLIPSE-STEMI trial. J Thromb Thrombolysis. 2023 Feb;55(2):203-210. doi: 10.1007/s11239-022-02737-y. Epub 2022 Dec 8.

    PMID: 36480147DERIVED

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • David Vivas, MD, PhD

    San Carlos University Hospital, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Vivas, MD, PhD

CONTACT

0034 913303149dvivas@secardiologia.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 8, 2016

First Posted

October 11, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

ES(1)