Cardiovascular DiseasePhase 2/3NCT00501254
Pharmacodynamic Trial, of Slow Release ASA, in Platelet Functionalism, a Long Term Treatment Period
A Phase 2/3 study testing Slow release acetyl salicylic acid and Antithrombotic effect in people with Cardiovascular Disease, run by Rottapharm Spain at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Slow release acetyl salicylic acid and Antithrombotic effect
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2005to Feb 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous episodes of myocardial infarction
- Previous episodes of instable angina pectoris
- Previous coronary revascularization
- Significant arterial coronary disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Slow release acetyl salicylic acid, Antithrombotic effect
- Keywords
- Slow release ASA, Platelet functionalism, Secondary cardiovascular prevention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow release acetyl salicylic acidDrug
Antithrombotic effectBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation
Measured: one year
Secondary outcomes (1)
Safety profile of the two different formulations of ASA (Slow Release and Normal Release)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startFeb 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rottapharm Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eloy Rueda, MD, Principal investigator, Hosp. Universitario Virgen de la Victoria, Málaga (Spain)José Pedro de la Cruz, MD, phD, Principal investigator, Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de MálagaJosé Antonio González Correa, MD, phD, Principal investigator, Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501254
- Sponsor's protocol ID
- TROM-EC-ECC-01
- Other IDs
- EudraCT number: 2004-000398-76
- Status last verified
- Jul 2007
- First submitted
- 13 Jul 2007
- Last updated
- 18 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00501254
- Acronym / sponsor ID
- TROM-EC-ECC-01
- Conditions
- Cardiovascular Disease
- Keywords
- Slow release ASA, Platelet functionalism, Secondary cardiovascular prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rottapharm SpainIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous episodes of myocardial infarction
- Previous episodes of instable angina pectoris
- Previous coronary revascularization
- Significant arterial coronary disease
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow release acetyl salicylic acid | Drug | – |
| Antithrombotic effect | Behavioural | – |
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
Time frame: one year
1 secondary outcome
Safety profile of the two different formulations of ASA (Slow Release and Normal Release)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eloy Rueda, MD principal investigator
Hosp. Universitario Virgen de la Victoria, Málaga (Spain)
José Pedro de la Cruz, MD, phD principal investigator
Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
José Antonio González Correa, MD, phD principal investigator
Departamento de Farmacología y Terapéutica Clínica Facultad de Medicina, Universidad de Málaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Slow release acetyl salicylic acid and Antithrombotic effect in people with Cardiovascular Disease, run by Rottapharm Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of the effect of treatment with slow release ASA on the tromboxane/prostacyclin balance and its repercusion in the platelet aggregation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2007.