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

This study has been completed.
Sponsor:
Information provided by:
Rottapharm Spain
ClinicalTrials.gov Identifier:
NCT00501254
First received: July 13, 2007
Last updated: July 17, 2007
Last verified: July 2007
History of Changes
  Purpose

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 Intervention Phase
Cardiovascular Disease
 Drug: Slow release acetyl salicylic acid
Behavioral: Antithrombotic effect
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rottapharm Spain:

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

Enrollment: 100
Study Start Date: February 2005
Study Completion Date: February 2007
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501254

Locations
Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Sponsors and Collaborators
Rottapharm Spain
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00501254     History of Changes
Other Study ID Numbers: TROM-EC-ECC-01, EudraCT number: 2004-000398-76
Study First Received: July 13, 2007
Last Updated: July 17, 2007
Health Authority: Spain: Spanish Agency of Medicines

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

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

ClinicalTrials.gov processed this record on May 23, 2013