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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00501254

Enrollment

100

Registered

2007-07-16

Start date

2005-02-28

Completion date

2007-02-28

Last updated

2007-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Slow release ASA, Platelet functionalism, Secondary cardiovascular prevention

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.

Interventions

DRUGSlow release acetyl salicylic acid

BEHAVIORALAntithrombotic effect

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation	one year

Secondary

Measure	Time frame
Safety profile of the two different formulations of ASA (Slow Release and Normal Release)	one year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026