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)

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) - ECCLIPSE-STEMI trial

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000054-35-ES

Enrollment

Registered

2016-05-17

Start date

2016-05-20

Completion date

Unknown

Last updated

2016-05-30

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

Conditions

Myocardial Infarction MedDRA version: 19.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: INYESPRIN Pharmaceutical Form: Solution for infusion INN or Proposed INN: LYSINE ASPIRIN CAS Number: 62952-06-1 Current Sponsor code: test Other descriptive name: LYSINE ASPIRIN Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age ?18 years - Patient with acute myocardial infarction with ST segment elevation. - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: - Allergy to aspirin, lysine acetylsalicylate , clopidogrel, prasugrel or ticagrelor . - Blood dyscrasias , including a history of thrombocytopenia. - Recent Antiplatelet therapy ( 2.5 times the normal limit . - Active Neoplasia . - Pregnancy and lactation. - Concomitant terminal disease . - Inclusion in another clinical trial .

Design outcomes

Primary

Measure	Time frame
Main Objective: -To compare the platelet aggregation at 30 minutes after administration of intravenous loading dose AL against an oral aspirin loading .;Secondary Objective: - To compare platelet aggregation: basal hour, 4 hours and 24 hours after administration of both treatment groups . - To compare platelet reactivity throughout the time sequence in both treatment groups . - To assess the safety of the treatment administered.;Primary end point(s): Platelet reactivity;Timepoint(s) of evaluation of this end point: 30 minutes	—

Measure

Time frame

Main Objective: -To compare the platelet aggregation at 30 minutes after administration of intravenous loading dose AL against an oral aspirin loading .;Secondary Objective: - To compare platelet aggregation: basal hour, 4 hours and 24 hours after administration of both treatment groups . - To compare platelet reactivity throughout the time sequence in both treatment groups . - To assess the safety of the treatment administered.;Primary end point(s): Platelet reactivity;Timepoint(s) of evaluation of this end point: 30 minutes

—

Secondary

Measure	Time frame
Secondary end point(s): - Platelet Reactivity. - Inhibition of platelet reactivity (IRP ). - Incidence of adverse events.;Timepoint(s) of evaluation of this end point: baseline , at the time , 4 hours and 24 hours after administration of study medication .	—

Countries

Spain

Contacts

Public ContactUICEC

Fundación para la investigación biomédica del hospital clinico san carlos de madrid

fibucicec.hcsc@salud.madrid.org+349133030007360

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026