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

Information source: Rottapharm Spain
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular Disease

Intervention: slow release acetyl salicylic acid (Drug); ASA (Drug); SR-ASA (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Rottapharm Spain

Official(s) and/or principal investigator(s):
Eloy Rueda, MD, Principal Investigator, Affiliation: Hosp. Universitario Virgen de la Victoria, Málaga (Spain)
José Pedro de la Cruz, PhD, Principal Investigator, Affiliation: Departmento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
José Antonio González Correa, PhD, Principal Investigator, Affiliation: Departamento de Farmacología y Terapéutica Clínica Facultad de Medicna, Universidad de Málaga

Summary

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: 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

Secondary outcome: To evaluate the principal kinetic parameters of both galenic formulations of ASA.

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hospital Universitario Virgen de la Victoria, Málaga 29010, Spain
Additional Information

Starting date: January 2007
Last updated: June 7, 2011

Page last updated: August 23, 2015

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