NCT00501254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
Last Updated

July 18, 2007

Status Verified

July 1, 2007

First QC Date

July 13, 2007

Last Update Submit

July 17, 2007

Conditions

Cardiovascular Disease

Keywords

Slow release ASAPlatelet functionalismSecondary cardiovascular prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety profile of the two different formulations of ASA (Slow Release and Normal Release)

    one year

Interventions

Slow release acetyl salicylic acidDRUG
Antithrombotic effectBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous episodes of myocardial infarction
  • Previous episodes of instable angina pectoris
  • Previous coronary revascularization
  • Significant arterial coronary disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

February 1, 2005

Study Completion

February 1, 2007

Last Updated

July 18, 2007

Record last verified: 2007-07

Locations

ES(1)