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

Phase 2

Completed

• Conditions: Cardiovascular Disease

• Registration Number: NCT00501254
• Lead Sponsor: Rottapharm Spain

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.

Study Timeline

• Study Start: 2005-02
• Study Completion: 2007-02
• Status Verified: 2007-07
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Last Update Submitted: 2007-07-17
• Last Update Posted: 2007-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation	one year

Secondary Outcome Measures

Name	Time	Method
Safety profile of the two different formulations of ASA (Slow Release and Normal Release)	one year

Trial Locations

Locations (1)

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