Pharmacodynamic Trial, of Slow Release ASA, in Platelet Functionalism, a Long Term Treatment Period
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.
Drug: Slow release acetyl salicylic acid
Behavioral: Antithrombotic effect
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||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|
- The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation [ Time Frame: one year ]
- Safety profile of the two different formulations of ASA (Slow Release and Normal Release) [ Time Frame: one year ]
|Study Start Date:||February 2005|
|Study Completion Date:||February 2007|
- 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.
|Hospital Universitario Virgen de la Victoria|
|Principal Investigator:||Eloy Rueda, MD||Hosp. Universitario Virgen de la Victoria, Málaga (Spain)|
|Principal Investigator:||José Pedro de la Cruz, MD, phD||Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga|
|Principal Investigator:||José Antonio González Correa, MD, phD||Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga|