Pharmacodynamic-pharmacokinetic Trial, of Slow Release ASA, in the Platelet Functionalism.

Pharmacodynamic- Pharmacokinetic Trial, Comparative Double Blind, of the Chronic Administration of 150 mg of Slow Release ASA Versus 150 mg of Normal Release ASA, in the Platelet Functionalism.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00425074

Enrollment

Registered

2007-01-22

Start date

2007-01-31

Completion date

2007-07-31

Last updated

2011-06-08

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

The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA: normal and the one of sustained release, in patients with stable coronary disease.

Detailed description

A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication. Without doubt, the acetylsalicylic acid (ASA) is the most used antiaggregant product, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanism of action implicated, the association with other drugs, and the pharmaceutical form in order to improve the efficacy and the 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 of ASA.

Interventions

DRUGslow release acetyl salicylic acid

150 mg in capsules via oral, during 14 days.

DRUGASA

normal release acetylsalicylic acid

DRUGSR-ASA

slow release acetylsalicylic acid 150 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

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 requires treatment with other antiaggregants * Patients in treatment with low molecular weight heparin or oral anticoagulant * Patients with antecedents of hypersensibility to ASA

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of the treatment with ASA (150 mg) produces on the thromboxan/prostacyclin balance and its repercussion in the platelet aggregation,comparing this effect between two formulations	28 days

Secondary

Measure	Time frame
To evaluate the principal kinetic parameters of both galenic formulations of ASA.	28 days

Countries

Spain

Outcome results

None listed

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