Clinical trial NCT00501254: Pharmacodynamic Trial, of Slow Release ASA, in Platelet Functionalism, a Long Term Treatment Period
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cardiovascular Disease
Keywords: Slow release ASA
Platelet functionalism
Secondary cardiovascular prevention
Lead sponsor: Rottapharm Spain
Sponsor class: INDUSTRY
First posted: 2007-07-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: * 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.

Eligibility 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 require treatment with other antiaggregants
* Patients in treatment with low molecular weight heparin or oral anticoagulants
* Patients with antecedents of hypersensibility to ASA

Primary outcomes:
measure: The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation
timeFrame: one year
Secondary outcomes:
measure: Safety profile of the two different formulations of ASA (Slow Release and Normal Release)
timeFrame: one year
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: Hosp. Universitario Virgen de la Victoria, Málaga (Spain)
name: Eloy Rueda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
name: José Pedro de la Cruz, MD, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
name: José Antonio González Correa, MD, phD
role: PRINCIPAL_INVESTIGATOR
References: