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Trial record 43 of 508 for:    ASPIRIN AND P2

Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate in STEMI Patients (ECCLIPSE-STEMI)

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ClinicalTrials.gov Identifier: NCT02929888
Recruitment Status : Unknown
Verified October 2016 by David Vivas, Fundacion Investigacion Interhospitalaria Cardiovascular.
Recruitment status was:  Recruiting
First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
David Vivas, Fundacion Investigacion Interhospitalaria Cardiovascular

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

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Lysine Acetilsalicilate Drug: Aspirin Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : October 2016
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Lysine Acetilsalicilate (LA)
Loading dose (LD) of intravenous LA 450mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction
Drug: Lysine Acetilsalicilate
Active Comparator: Aspirin
Loading dose (LD) of oral aspirin 300mg plus oral prasugrel 60mg/ticagrelor 180mg in patients with ST-segment elevation myocardial infarction
Drug: Aspirin



Primary Outcome Measures :
  1. Inhibition of platelet aggregation [ Time Frame: 30 min ]
    The primary endpoint of the study, inhibition of platelet aggregation after arachidonic acid (AA) 1.5mM at 30 min


Secondary Outcome Measures :
  1. Inhibition of platelet aggregation [ Time Frame: 30 min, 1h, 4h, 24h ]
    Inhibition of platelet aggregation using different platelet function test (ADP, collagen, VASP)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929888


Contacts
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Contact: David Vivas, MD, PhD 0034 913303149 ext 3149 dvivas@secardiologia.es

Locations
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Spain
Fundacion Recruiting
Madrid, Spain, 28040
Contact: David Vivas, MD, PhD    0034913303149 ext 3149    dvivas@secardiologia.es   
Sponsors and Collaborators
Fundacion Investigacion Interhospitalaria Cardiovascular
Investigators
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Principal Investigator: David Vivas, MD, PhD San Carlos University Hospital, Madrid, Spain

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Responsible Party: David Vivas, MD, PhD, Fundacion Investigacion Interhospitalaria Cardiovascular
ClinicalTrials.gov Identifier: NCT02929888     History of Changes
Other Study ID Numbers: 2016-ECCLIPSESTEMI-01
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Keywords provided by David Vivas, Fundacion Investigacion Interhospitalaria Cardiovascular:
ST-segment elevacion myocardial infarction, platelets
Additional relevant MeSH terms:
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Aspirin
Acetylsalicylic acid lysinate
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics