Patients with moderate/high cardiovascular risk
Conditions
Interventions
Product Name: Acetylsalycilic acid 20 mg
Product Code: ASA-20
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: acetylsalicylic acid
CAS Number: 50-78-2
Other descriptive name: ACETYL SALICY
Sponsors
IRCCS San Raffaele di Roma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •men or women •age > 18 years •moderate-high cardiovascular risk, assessed by using the SCORE system (=1% and =65 years) yes F.1.3.1 Number of subjects for this age range 131
Exclusion criteria
Exclusion criteria: •Age 400 000 per mm3) or with other acquired causes of impaired platelet aggregation, including uremia and paraproteinemia (monoclonal gammopathy). •Patients with haemophilia or other bleeding disorders •Patients with myeloproliferative disorders •Patients with severe chronic kidney disease (GFR ,30 mL/min/ 1.73 m2), using Cockcroft’s formula: o men = (140 - age) x weight (kg)/(0.814 x creatinine level (µmol/lL)). o women = 0.85 x [(140 - age) x weight (kg)/(0.814 x creatinine level (µmol/lL))]. •Patients with known liver disease or biliary disease (chronic hepatitis, cirrhosis, etc) or with ALAT or ASAT upper than 3 times the upper limit of normal laboratory range. •Patient with hyperkalemia •History of alcoholism or drug abuse. •Patients unlikely to co-operate in the study or to comply well with treatment or with the study visits. •Participation in another study at the same time or within the preceding 30 days, (or a longer period in accordance to the local regulations). •History of severe disease likely to interfere with the conduct of the study, severe uncontrolled infection, evolving neoplasm. •History of severe mental or psychiatric disorder, severe depression or history of severe depression, e.g. requiring an hospitalisation or at high risk of suicide attempt. •Endocrine diseases: uncontrolled dys-thyroidia, Cushing’s syndrome, acromegalia, hyperparathyroidia. •Patient with a life expectancy of less than the 15 month duration of the study in opinion to the investigator. •Patients with HIV or taking drugs for HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non inferiority of two different dosages (20 mg or 40 mg) of sublingual preparation of aspirin in comparison to the oral formulation of aspirin (100 mg) on inhibition of platelet aggregation, assessed by 1. Efficacy a) plasma thromboxane B2 b) platelet aggregation 2. Safety a) adverse events, with particular regards for GI symptoms b) blood clinical laboratory parameters (haematology and biochemistry) c) fecal occult blood d) systolic blood pressure and diastolic blood pressure ;Secondary Objective: Efficacy 1) urinary 11-dehydro thromboxane B2 2) plasmatic and urinary 6-keto-PGF1a ;Primary end point(s): The Primary Efficacy Endpoint for the trial is the change in platelet aggregation effect after 12 week of treatment, assessed by: a) measure of plasma thromboxane B2 analyzed by EIA Biotrak systems b) platelet aggregation tested in platelet rich plasma ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The Secondary Efficacy Endpoints for the trial are the changes after 12 week of treatment, of: a) urinary 11-dehydro thromboxane B2 b) plasmatic and urinary 6-keto-PGF1a ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Italy
Contacts
Public ContactRegulatory Affairs Department
TFS Trial Form Support S.r.l.
Outcome results
None listed