Pharmacodynamic-pharmacokinetic Trial, of Slow Release ASA, in the Platelet Functionalism.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA: normal and the one of sustained release, in patients with stable coronary disease.

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. Without doubt, the acetylsalicylic acid (ASA) is the most used antiaggregant product, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanism of action implicated, the association with other drugs, and the pharmaceutical form in order to improve the efficacy and the 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 of ASA.

Official Title
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Pharmacodynamic- Pharmacokinetic Trial, Comparative Double Blind, of the Chronic Administration of 150 mg of Slow Release ASA Versus 150 mg of Normal Release ASA, in the Platelet Functionalism.

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Drug: slow release acetyl salicylic acid
* Drug: ASA
* Drug: SR-ASA


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 requires treatment with other antiaggregants Patients in treatment with low molecular weight heparin or oral anticoagulant 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SR-ASA<br>slow release acetylsalicylic acid 150 mg | Drug: slow release acetyl salicylic acid<br>* 150 mg in capsules via oral, during 14 days.<br>Drug: SR-ASA<br>* slow release acetylsalicylic acid 150 mg<br>|
| Active Comparator: ASA<br>normal release acetylsalicylic acid | Drug: ASA<br>* normal release acetylsalicylic acid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of the treatment with ASA (150 mg) produces on the thromboxan/prostacyclin balance and its repercussion in the platelet aggregation,comparing this effect between two formulations |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the principal kinetic parameters of both galenic formulations of ASA. |  | 28 days | 

 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