EUCTR2013-002980-24-IT
Active, not recruiting
Not Applicable
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 - ASA-001
IRCCS San Raffaele di Roma0 sites261 target enrollmentAugust 9, 2013
DrugsCARDIOASPIRIN® 100
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IRCCS San Raffaele di Roma
- Enrollment
- 261
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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