Pharmacodynamic Trial, of Slow Release ASA, in Platelet Functionalism, a Long Term Treatment Period
Information source: Rottapharm Spain
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiovascular Disease
Intervention: Slow release acetyl salicylic acid (Drug); Antithrombotic effect (Behavioral)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Rottapharm Spain Official(s) and/or principal investigator(s):
Eloy Rueda, MD, Principal Investigator, Affiliation: Hosp. Universitario Virgen de la Victoria, Málaga (Spain)
José Pedro de la Cruz, MD, phD, Principal Investigator, Affiliation: Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
José Antonio González Correa, MD, phD, Principal Investigator, Affiliation: Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation
Secondary outcome: Safety profile of the two different formulations of ASA (Slow Release and Normal Release)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hospital Universitario Virgen de la Victoria, Málaga, Spain
Additional Information
Starting date: February 2005
Last updated: July 17, 2007
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