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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00501254
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : July 18, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Slow release acetyl salicylic acid Behavioral: Antithrombotic effect Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official 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
Study Start Date : February 2005
Study Completion Date : February 2007

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00501254

Hospital Universitario Virgen de la Victoria
Málaga, Spain
Sponsors and Collaborators
Rottapharm Spain
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 Identifier: NCT00501254     History of Changes
Other Study ID Numbers: TROM-EC-ECC-01
EudraCT number: 2004-000398-76
First Posted: July 16, 2007    Key Record Dates
Last Update Posted: July 18, 2007
Last Verified: July 2007

Keywords provided by Rottapharm Spain:
Slow release ASA
Platelet functionalism
Secondary cardiovascular prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors