Comparative effect of acetylsalicylic acid on platelet aggregation sublingual.

• Conditions: Patients with moderate/high cardiovascular risk; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002980-24-IT
• Lead Sponsor: IRCCS San Raffaele di Roma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-09
• Last Update Posted: 19 May 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 261

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

Exclusion Criteria

•Age < 18 years
•Positive pregnancy test (ßGCH) performed at the selection visit or results not available, women who are pregnant, women who are breast-feeding, women of childbearing potential who are not using reliable methods available to avoid pregnancy
•Patients at very high or low cardiovascular risk, having a calculated SCORE =10%
•History of atrial fibrillation or atrial flutter
•Patient in treatment with indication to oral anticoagulants or other antithrombotic drugs
•Patient with history of hypersensitivity or intolerance with acetylsalicylic acid or other non steroidal ant-iinflammatory drugs (NSAIDs)
•Patients with any history of hereditary angioedema hereditary, idiopathic or associated with acetylsalicylic acid
•Patients with history of peptic ulcers or gastritis or history of gastrointestinal bleeding associated to acetylsalicylic acid or other non steroidal anti-inflammatory drugs (NSAIDs)
•Patients with severe gastro-intestinal tract disorders
•Patient with asthma or NSAID-precipitated bronchospasm
•Patients with known coagulation disorders or with abnormal platelet count (< 100 000 per mm3 or > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified