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

Phase 1

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: slow release acetyl salicylic acid; Drug: ASA; Drug: SR-ASA

• Registration Number: NCT00425074
• Lead Sponsor: Rottapharm Spain

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.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-19
• Study First Submitted QC: 2007-01-19
• Study First Posted: 2007-01-22
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SR-ASA	slow release acetyl salicylic acid	slow release acetylsalicylic acid 150 mg
SR-ASA	SR-ASA	slow release acetylsalicylic acid 150 mg
ASA	ASA	normal release acetylsalicylic acid

Primary Outcome Measures

Name	Time	Method
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	28 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the principal kinetic parameters of both galenic formulations of ASA.	28 days

Trial Locations

Locations (1)

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain