NCT02243137

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

June 24, 2013

Last Update Submit

September 15, 2014

Conditions

Adverse Effect of Antithrombotic Drugs

Outcome Measures

Primary Outcomes (1)

  • Inhibition of platelet aggregation

    measured by light transmission aggregometry

    at 30 minutes

Secondary Outcomes (3)

  • Inhibition of platelet aggregation

    baseline, 1 h, 4 h and 34 h

  • Inhibition of platelet reactivity

    baseline, 1 h, 4 h and 34 h

  • Incidence of adverse events

    baseline, 30 min, 1 h, 4 h, and 24 h

Study Arms (2)

prasugrel and acetylsalicylic

ACTIVE COMPARATOR

single dose of prasugrel 60 mg orally and 300 mg acetylsalicylic acid orally

Drug: acetylsalicylic acidDrug: prasugrel

lysine acetylsalicylate and prasugrel

EXPERIMENTAL

single dose of prasugrel 60 mg oral and lysine acetylsalicylate 450 mg intravenous

Drug: prasugrelDrug: lysine acetylsalicylate

Interventions

acetylsalicylic acidDRUG

Administration: one dose of Acetylsalicylic Acid (300mg)

Also known as: Adiro
prasugrel and acetylsalicylic
prasugrelDRUG

Administration: one loading dose (60mg)

Also known as: Effient
lysine acetylsalicylate and prasugrelprasugrel and acetylsalicylic
lysine acetylsalicylateDRUG

Administration: one dose (450mg iv)

Also known as: Inyesprin
lysine acetylsalicylate and prasugrel

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital ClĂ­nico San Carlos

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

  • Vivas D, Martin A, Bernardo E, Ortega-Pozzi MA, Tirado G, Fernandez C, Vilacosta I, Nunez-Gil I, Macaya C, Fernandez-Ortiz A. Impact of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Prasugrel-Inhibited Platelets: Results of a Prospective, Randomized, Crossover Study (the ECCLIPSE Trial). Circ Cardiovasc Interv. 2015 May;8(5):e002281. doi: 10.1161/CIRCINTERVENTIONS.114.002281.

    PMID: 25957056DERIVED

MeSH Terms

Interventions

AspirinPrasugrel Hydrochlorideacetylsalicylic acid lysinate

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiophenesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • David Vivas, MD, PhD

    San Carlos University Hospital, Madrid Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 24, 2013

First Posted

September 17, 2014

Study Start

May 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

ES(1)