Clinical trial NCT00425074: Pharmacodynamic-pharmacokinetic Trial, of Slow Release ASA, in the Platelet Functionalism.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Disease
Keywords: slow release ASA
platelet functionalism
secondary cardiovascular prevention
Lead sponsor: Rottapharm Spain
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 50
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: 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: 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 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

Primary outcomes:
measure: 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
timeFrame: 28 days
Secondary outcomes:
measure: To evaluate the principal kinetic parameters of both galenic formulations of ASA.
timeFrame: 28 days
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: Departmento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
name: José Pedro de la Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Departamento de Farmacología y Terapéutica Clínica Facultad de Medicna, Universidad de Málaga
name: José Antonio González Correa, PhD
role: PRINCIPAL_INVESTIGATOR
References: