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

Rottapharm

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Disease

Treatments: Drug: slow release acetyl salicylic acid; Drug: SR-ASA; Drug: ASA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00425074

TROM-EC-ECC-FIb

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 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 requires treatment with other antiaggregants
• Patients in treatment with low molecular weight heparin or oral anticoagulant
• Patients with antecedents of hypersensibility to ASA

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

SR-ASA

Experimental group

Description:

slow release acetylsalicylic acid 150 mg

Treatment:

Drug: SR-ASA

Drug: slow release acetyl salicylic acid

ASA

Active Comparator group

Description:

normal release acetylsalicylic acid

Treatment:

Drug: ASA