We will perform this clinical study to address the hypothesis that low-dose aspirin given once daily is acting primarily by selectively acetylating platelet COX-1 and suppressing its activity throughout the 24-hour dosing interval.
Conditions
Interventions
Trade Name: Adiro 100 mg
Product Name: Adiro 100 mg
Product Code: B01AC06
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
Other descriptive name: ACETYLSALICYLIC ACID
Concentrati
Sponsors
Insituto Aragonés de Ciencias de la Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients should be ? 18 years and no older than 69 2.Patients should have an indication for screening colonoscopy (patients > 50 years or personal or familiar history of CCR or adenomas ) a.First degree relative of patient with CRC. b.Personal history of adenomas. c.People older than 50 and FOBT positive 3.Routine hematological and biochemical parameters within the normal range 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1.Allergy to aspirin or other NSAIDs. 2.Previous use of aspirin, NSAIDS, antiplatelet agents, corticosteroids or misoprostol in the previous 15 days and/or anticipated need for these drugs during the study period. 3.Peptic ulcer history or any other gastrointestinal disease that could be considered a contraindication for aspirin use without the concomitant use of a proton-pump inhibitor 4.Subjects with a bleeding disorder 5.Malignancies, excluding CRC, diagnosed in the previous 5 years 6.Serious comorbid condition, including pulmonary, cardiac, liver or kidney diseases, cigarette smoking, history of drug or alcohol abuse 7.Pregnant women or breast feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary end-point of the study will be the assessment of COX-1 acetylation in platelets versus nucleated cells of the colonic tissue, at 24 h after dosing.;Timepoint(s) of evaluation of this end point: During the days of the follow up time. For more information check the schedule of events;Main Objective: To verify whether low-dose aspirin (administered for 1 week to obtain a steady-state acetylation of platelet COX-1) causes virtually complete acetylation of COX-1 in platelets, while no acetylated COX-1 is detected in nucleated cells of the colonictissue 24 hours after dosing;Secondary Objective: - To assess whether at the time when aspirin (enteric coated) reaches the systemic circulation, COX-1 of both platelets and left and right mucosal colonic tissues will be acetylated but the extent of acetylation will be higher in platelets than in recto-colonic tissues. -To study the inhibition of platelet COX-1 activity and platelet function by aspirin administration and to verify whether these effects lead to changes in platelet and plasma proteome - To assess the effect of aspirin administration on eicosanoid biosynthesis, S1P levels and protein expression of markers of cell growth and progression, in normal tissues or pathological recto-colonic tissues -To assess the effect of aspirin on systemic markers of prostanoid biosynthesis in vivo by measuring in urine samples their enzymatic metabolites | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): We hypothesize that the inhibitory effect on extra-platelet sources of COX-1 will be short-lasting, if any, affecting only partially COX-1, and this effect will be completely reversed at 24 hours after dosing;Timepoint(s) of evaluation of this end point: During the days of the follow up time. For more information check the schedule of events | — |
Countries
Spain
Contacts
Public ContactEva Lopez Hernández
Instituto Aragonés de Ciencias de la Salud
Outcome results
None listed