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

Rottapharm

Status and phase

Completed

Phase 3

Phase 2

Conditions

Cardiovascular Disease

Treatments

Behavioral: Antithrombotic effect

Drug: Slow release acetyl salicylic acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00501254

TROM-EC-ECC-01

EudraCT number: 2004-000398-76

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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