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)

Phase 1

• Conditions: Myocardial Infarction; MedDRA version: 19.0Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-000054-35-ES
• Lead Sponsor: Fundación Interhospitalaria Investigación Cardiovascular

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-17
• Last Update Posted: 30 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

- Allergy to aspirin, lysine acetylsalicylate , clopidogrel, prasugrel or ticagrelor .
- Blood dyscrasias , including a history of thrombocytopenia.
- Recent Antiplatelet therapy ( < 14 days) , including aspirin, lysine acetylsalicylate , clopidogrel, prasugrel , ticagrelor , cilostazol , dipyridamole , ticlopidine or glycoprotein IIb / IIIa .
- Chronic treatment with oral anticoagulants.
- Active bleeding .
- Recent history of stroke, transient ischemic attack or intracranial hemorrhage ( < 6 months prior to inclusion period ) .
- Severe renal impairment , defined as glomerular filtration rate ( Cockroft -Gault formula ) < 30 mL / min .
- Elevated transaminase > 2.5 times the normal limit .
- Active Neoplasia .
- Pregnancy and lactation.
- Concomitant terminal disease .
- Inclusion in another clinical trial .

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 .<br>- To compare platelet reactivity throughout the time sequence in both treatment groups .<br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Platelet Reactivity.<br>- Inhibition of platelet reactivity (IRP ).<br>- 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 .