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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501254
• Other study ID #: TROM-EC-ECC-01
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 13, 2007
• Last updated: July 17, 2007
• Start date: February 2005
• Est. completion date: February 2007

Study information

• Verified date: July 2007
• Source: Rottapharm Spain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Slow release acetyl salicylic acid

Behavioral:
• Antithrombotic effect

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Rottapharm Spain

Country where clinical trial is conducted

Spain, 

Outcome

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