To determine proteins in plasma, leukocytes and platelets associated with aspirin resistance syndrome in stable coronary artery disease patients that may allow us to identify them.It is probably that may also exist proteins that allows us to identify thienopyridine resistance Identificar en plasma, leucocitos y plaquetas proteínas asociadas con resistencia a aspirina en pacientes con enfermedad coronaria estable.Podrían existir proteínas que nos permitan identificar resistencia a tienopiridinas
Conditions
Interventions
Trade Name: prasugrel
Product Name: prasugrel
Product Code: prasugrel (CS747)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PRASUGREL
CAS Number: 389574-19-0
Current Sponsor code: CS-74
Sponsors
FUNDACIÓN INVESTIGACIÓN BIOMEDICA DEL HOSPITAL CLINICO SAN CARLOS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Men and women, ages 18 or older -Documented history of coronary disease define as >50% stenosis in >/= 1 major coronary artery, clinically stable for at least 6 months. -Stable clinical situation at least during the last month. -Patients receiving AAS 100 mg daily at least during the last month and with the last AAS dosage 24 hours before -Written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Another antithrombotic treatment than AAS in the previous month -Presence of active infectious or tumoral disease -Recent trauma or major surgery, angioplasty or cathetherism during the last month -Atorvastatin treated patients -Patients receiving antiinflammatory treatment during the last month -No written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To develop the protein expression map of plasma from stable coronary artery disease patients with and without plasma resistance, using as reference their platelet functionality. In the case of identify a protein or protein isoform related with aspirin resistance we also will determine if this protein modifies aspirin inhibition of platelet COX-1.;Secondary Objective: -To develop the protein expression map of platelets from stable coronary disease patients with and without aspirin resistance, using as reference their platelet functionality. -To develop the protein expression map o mononuclear cells from stable coronary disease patients with and without aspirin resistance using as reference their platelet functionality -To identify if clopidogrel or prasugrel administration inhibits, at different way, the platelet activation in aspirin resistant patients. -To identify if there are proteins or proteins isoforms related with clopidogrel or prasugrel resitance, using as reference their platelet functionality;Primary end point(s): The primary efficacy objective of this study will be to identify in plasma, mononuclear cells and platelets protein changes related with the aspirin resistance and thienopyridine resistance syndrome in coronary stable patients, determined by proteomics. Different kind of proteins will be identified in the three types of samples. Primary endpoints: -platelet functionality using the PFA-100 system -Expression of plasma proteins (examples of proteins that will be identified: alpha 1-antitrypsin isoforms, Albumin, fibrinogen gamma chain isoforms, vitamin D binding protein isoforms, Ceruloplasmin, Apolipoprotein AIV, Apolipoproteína AI isoforms, Tropomiosin isoforms, serotransferrine isoforms, haptoglobin isoforms etc..). -Expression of platelt proteins (examples of proteins that will be identified:Proteins related with the energetic metabolism such as Piruvate Kinase, Lactate Dehydrogenase, phosphodisulfide-Isomerase, Gliceraldehido | — |
Countries
Spain
Outcome results
None listed