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

Tracking Information

First Received Date ^ICMJE

July 13, 2007

Last Updated Date

July 17, 2007

Start Date ^ICMJE

February 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Synthesis of nitric oxid [ Time Frame: one year ]
Determination of the maximum intensity in the platelet aggregation induced by collagen and arachidonic acid [ Time Frame: one year ]
Parameters related with the prostanoid synthesis: plasmatic TxB2 (thromboxane) and 6-keto-PGF1a (prostacyclin) [ Time Frame: one year ]

Change History

Complete list of historical versions of study NCT00501254 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety profile of the two different formulations of ASA (Slow Release and Normal Release) [ Time Frame: one year ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Cardiovascular Disease

Intervention ^ICMJE

Drug: Slow release acetyl salicylic acid
Behavioral: Antithrombotic effect

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT ID ^ICMJE

NCT00501254

Responsible Party

Study ID Numbers ^ICMJE

TROM-EC-ECC-01, EudraCT number: 2004-000398-76

Study Sponsor ^ICMJE

Madaus, S.A.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Eloy Rueda, MD	Hosp. Universitario Virgen de la Victoria, Málaga (Spain)
Principal Investigator:	José Pedro de la Cruz, MD, phD	Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
Principal Investigator:	José Antonio González Correa, MD, phD	Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga

Information Provided By

Madaus, S.A.

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP