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

NCT ID: NCT00501254

Last Updated: 2007-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-02-28

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.

Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Slow release acetyl salicylic acid

Intervention Type DRUG

Antithrombotic effect

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rottapharm Spain

INDUSTRY

Sponsor Role lead

Principal Investigators

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Eloy Rueda, MD

Role: PRINCIPAL_INVESTIGATOR

Hosp. Universitario Virgen de la Victoria, Málaga (Spain)

José Pedro de la Cruz, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga

José Antonio González Correa, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga

Locations

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Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Site Status

Countries

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Spain

Other Identifiers

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EudraCT number: 2004-000398-76

Identifier Type: -

Identifier Source: secondary_id

TROM-EC-ECC-01

Identifier Type: -

Identifier Source: org_study_id