Skip to main content
OpenTrials
Completed

NCT Number: NCT00501254

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

slow release acetyl salicylic acid

Drug

Antithrombotic effect

Behavioral

Primary outcomes

  1. The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation

    Time frame: one year

Secondary outcomes

  1. Safety profile of the two different formulations of ASA (Slow Release and Normal Release)

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Rottapharm Spain

Industry

Registry information

Official study title

Randomised Clinical Trial, Parallel, Double Blind, to Evaluate the Influence of the ASA-SR (Slow-Release) in the Platelet Parameters and the Oxidative Status, in Patients With Coronary Disease of Chronic Evolution During 12 Months

Important dates

Study start
2005
Study completion
2007
First posted
Jul 16, 2007
Registry last updated
Jul 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.