Status:
COMPLETED
Study of Platelet Function After Administration of Aspirin Versus Lysine Acetylsalicylate
Lead Sponsor:
David Vivas
Collaborating Sponsors:
St Carlos Hospital, Madrid, Spain
Conditions:
Adverse Effect of Antithrombotic Drugs
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a phase I clinical trial in healthy volunteers comparing the effect of lysine acetylsalicylate or aspirin on platelet function.
Detailed Description
1\. SUMMARY 1.1. Type of trial Phase I clinical trial in healthy volunteers and marketed drugs 1.2. Identification of the promoter (correspondence to) Dr. David Vivas Balcones Cardiology Department Ho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02243137
Start Date
May 1 2013
End Date
June 1 2014
Last Update
September 17 2014
Active Locations (1)
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1
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040