Comparative study to evaluate the effect on platelet aggregation of two different doses (20 and 40 mg) of acetylsalicylic acid administered sublingually compared to the dose of 100 mg of acetylsalicylic acid orally in subjects at increased cardiovascular risk. Prospective, randomized, double-blind, parallel-group for a period of three months

INTERVENTION: 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 SALICYLIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Sublingual tablet Route of administration of the placebo: Sublingual use Product Name: Acetylsalycilic acid 40 mg Product Code: ASA‐40 Pharmaceutical Form: Sublingual tablet INN or Proposed INN: acetylsalicylic acid CAS Number: 50‐78‐2 Other descriptive name: ACETYLSALICYLIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Sublingual tablet Route of administration of the placebo: Sublingual use Trade Name: CARDIOASPIRIN® 100 Product Name: Cardioaspirin 100 Pharmaceutical Form: Tablet INN or Proposed INN: acetylsalicylic acid CAS Number: 50‐78‐2 Other descriptive name: ACETYLSALICYLIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Patients with moderate/high cardiovascular risk Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: 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; ; 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; Secondary Objective: Efficacy; 1) urinary 11‐dehydro thromboxane B2; 2) plasmatic and urinary 6‐keto‐PGF1a; ; Timepoint(s) of evaluation of this end point: 12 weeks SECONDARY OUTCOME: 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 INCLUSION CRITERIA: •men or women •age > 18 years •moderate‐high cardiovascular risk, assessed by using the SCORE system (=1% and <10% for 10‐year risk of fatal CVD), according to the European Guidelines on cardiovascular disease prevention in clinical practice •written informed 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 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 131