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

Acute Myocardial Infarction Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929888
• Other study ID #: 2016-ECCLIPSESTEMI-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 8, 2016
• Last updated: October 10, 2016
• Start date: October 2016

Study information

• Verified date: October 2016
• Source: Fundacion Investigacion Interhospitalaria Cardiovascular
• Contact: David Vivas, MD, PhD
• Phone: 0034 913303149
• Email: dvivas[@]secardiologia.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Lysine Acetilsalicilate

• Aspirin

Locations

Country	Name	City	State
Spain	Fundacion	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Investigacion Interhospitalaria Cardiovascular

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Inhibition of platelet aggregation	Inhibition of platelet aggregation using different platelet function test (ADP, collagen, VASP)	30 min, 1h, 4h, 24h	No