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Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate (ECCLIPSE)

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ClinicalTrials.gov Identifier: NCT02243137
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Collaborator:
St Carlos Hospital, Madrid, Spain
Information provided by (Responsible Party):
David Vivas, Fundacion Investigacion Interhospitalaria Cardiovascular

Brief Summary:
This is a phase I clinical trial in healthy volunteers comparing the effect of lysine acetylsalicylate or aspirin on platelet function.

Condition or disease Intervention/treatment Phase
Adverse Effect of Antithrombotic Drugs Drug: acetylsalicylic acid Drug: prasugrel Drug: lysine acetylsalicylate Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Combinated Administration of Lysine Acetylsalicylate Versus Prasugrel and Aspirin on Platelet Aggregation in Healthy Volunteers
Study Start Date : May 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: prasugrel and acetylsalicylic
single dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally
Drug: acetylsalicylic acid
Administration: one dose of Acetylsalicylic Acid (300mg)
Other Name: Adiro

Drug: prasugrel
Administration: one loading dose (60mg)
Other Name: Effient

Experimental: lysine acetylsalicylate and prasugrel
single dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous
Drug: prasugrel
Administration: one loading dose (60mg)
Other Name: Effient

Drug: lysine acetylsalicylate
Administration: one dose (450mg iv)
Other Name: Inyesprin




Primary Outcome Measures :
  1. Inhibition of platelet aggregation [ Time Frame: at 30 minutes ]
    measured by light transmission aggregometry


Secondary Outcome Measures :
  1. Inhibition of platelet aggregation [ Time Frame: baseline, 1 h, 4 h and 34 h ]
    measured by light transmission aggregometry

  2. Inhibition of platelet reactivity [ Time Frame: baseline, 1 h, 4 h and 34 h ]
    by the platelet reactivity index (PRI)

  3. Incidence of adverse events [ Time Frame: baseline, 30 min, 1 h, 4 h, and 24 h ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-60 years.
  • BMI> 19kg/m2 and <29kg/m2.
  • Women of childbearing potential who are committed to use a medically effective contraception during their participation in the study, except hormonal contraceptives.
  • Percentage of inhibition of platelet aggregation after stimulation with high basal 20 mM ADP and arachidonic acid 1.5 mM> 70%.
  • No clinically significant deviation on physical examination, ECG or laboratory values in laboratory tests.
  • Signed informed consent

Exclusion Criteria:

  • Smoking
  • Drug abuse
  • Pregnant or lactating
  • Infection with Hepatitis B or C, or HIV
  • Known drug allergies
  • Family history of blood disorders or coagulation.
  • History of disease that alters the absorption, metabolism or excretion of drugs, including jaundice.
  • Personal history of bleeding and / or blood dyscrasias (especially hemophilia, hypoprothrombinemia), including vascular malformations reasonable suspicion.
  • History of any medically relevant condition
  • Background of major surgery in the last 3 months
  • Prescription of chronic medication in the 14 days prior to study participation.
  • Participation in another study involving the administration of an investigational product in the last 4 months or a product already on the market in the last three months.

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): NCT02243137


Locations
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Spain
Hospital Clínico San Carlos
Madrid, Spain, 28040
Sponsors and Collaborators
David Vivas
St Carlos Hospital, Madrid, Spain
Investigators
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Principal Investigator: David Vivas, MD, PhD San Carlos University Hospital, Madrid Spain

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Vivas, MD, PhD, Fundacion Investigacion Interhospitalaria Cardiovascular
ClinicalTrials.gov Identifier: NCT02243137     History of Changes
Other Study ID Numbers: 2012-ECCLIPSE-01
2012-001702-20 ( EudraCT Number )
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Aspirin
Acetylsalicylic acid lysinate
Platelet Aggregation Inhibitors
Prasugrel Hydrochloride
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics