Pharmacodynamic Trial, of Slow Release ASA, in Platelet Functionalism, a Long Term Treatment Period

Study Overview
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Brief Summary
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Evaluation of the pharmacodynamic profile (antiaggregant profile, balance of prostanoids and nitric oxid) of a ASA-SR (slow-release)formulation in comparison with a ASA NR (normal release), 150 mg, during 12 months of treatment.

Detailed Description
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A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication. The acetylsalicylic acid (ASA) is the most used antiaggregant substance, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanisms of action implicated, the association with oder drugs, and the pharmaceutical fom in order to improve the efficacy and safety of the ASA. Some previous studies indicate that the slow release form of ASA has a different behaviour in the platelet effect in comparison with plain formulation. The aim of this study is to demonstrate the best antiaggregant and safety profile of a low dose of a slow release formulation in a long term treatment period of one year.

Official Title
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Randomised Clinical Trial, Parallel, Double Blind, to Evaluate the Influence of the ASA-SR (Slow-Release) in the Platelet Parameters and the Oxidative Status, in Patients With Coronary Disease of Chronic Evolution During 12 Months

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: Slow release acetyl salicylic acid
* Behavioral: Antithrombotic effect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous episodes of myocardial infarction Previous episodes of instable angina pectoris Previous coronary revascularization Significant arterial coronary disease Exclusion Criteria: Patients with other pathologies that require treatment with other antiaggregants Patients in treatment with low molecular weight heparin or oral anticoagulants Patients with antecedents of hypersensibility to ASA

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Slow release acetyl salicylic acid|nan|
|Behavioral: Antithrombotic effect|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of the two different formulations of ASA (Slow Release and Normal Release) |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Slow release ASA, Platelet functionalism, Secondary cardiovascular prevention