Coronary Heart DiseaseNCT01820429
Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease
An observational study of Coronary Heart Disease and Non ST-elevation Acute Coronary Syndromes, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the response to aspirin in the acute phase with the late phase of an acute coronary syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Non ST-elevation Acute Coronary Syndromes
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2009to Apr 2012
- Phase
- Observational
- 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
Study population: 70 patients diagnosed with non ST acute coronary syndrome (unstable angina and myocardial infarction without ST elevation), with up to 48 hours of evolution from the onset of symptoms.
Who may be able to join
- Age ≥ 18 years
- Confirmed diagnosis of acute coronary syndrome without ST segment elevation, in the first 48 hours after the onset of the clinical symptoms
- Regular use of aspirin for at least seven days.
Who cannot join
- Previous use, in the last 7 days, of another antiplatelet agent than aspirin
- Use of antivitamin K in the last 3 weeks
- Hemoglobin < 10g/dL and / or hematocrit < 30% or > 50%, platelets count < 100.000/mm3 or > 500.000/mm3, creatinine clearance < 30 mL / minute
- Killip class III or IV
- Need for vasopressor or inotropic parenteral medication at inclusion in the study
- Percutaneous coronary intervention within 30 days or CABG in the last 90 days prior to study entry
Show all 10Show fewer
- Current malignancy
- Hematologic diseases
- Refusal to sign the inform consent form
- Unable to attend the second visit (follow-up) for any reason except for death
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School
São Paulo, São Paulo, 05403900
About this study
Official title: Residual Platelet Activity Despite Aspirin Utilization in Patients With Non ST Elevation Acute Coronary Syndromes: Comparison Between the Acute and Chronic Phases
The purpose of this study is to compare the response to aspirin in the acute phase with the late phase of an acute coronary syndrome.
Read the detailed description
The purpose of this study is to compare, in the same population, the response to aspirin in the initial phase (first 48 hours) with the late phase (after 3 months of discharge)of a non ST elevation acute coronary syndrome (angina or acute myocardial infarction).
- Keywords
- Platelet aggregation, Aspirin
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First 48 hours | Patients in the first 48 hours of non ST-elevation acute coronary syndromes. | |
| 3 months after discharge | Patients with 3 months after hospital discharge for non ST-elevation acute coronary syndromes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare platelet aggregation between the first 48 hours and 3 months after discharge.
Measured: 3 months
Secondary outcomes (5)
Relation between platelet aggregability and the composite endpoint of death, myocardial infarction, unstable angina and need for revascularization or hospitalization at 3 months after discharge.
Measured: 3 months
Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours.
Measured: 48 hours
Relation between C reactive protein and interleukin -6 with levels of platelet aggregation.
Measured: first 48 hours and 3 months
Relation between platelet aggregation and the presence or absence of selected polymorphisms.
Measured: first 48 hours and 3 months
Platelet aggregation in respect to age, gender, glucose at hospital arrival, glycated hemoglobin, statin, PPI, current smokers, ACE inhibitors, type of ACS presentation.
Cut point for age 65 y, for glycemia 125 mg/dL, for glycated hemoglobin 6%
Measured: first 48 hours and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Jose C Nicolau, MD, PhD, Study chair, Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820429
- Sponsor's protocol ID
- INCORPA
- Status last verified
- Mar 2013
- First submitted
- 10 Jul 2012
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Platelet Activity Despite Aspirin Utilization in Patients With Non ST Elevation Acute Coronary Syndromes: Comparison Between the Acute and Chronic Phases
- ClinicalTrials.gov ID
- NCT01820429
- Acronym / sponsor ID
- INCORPA
- Keywords
- Platelet aggregation, Aspirin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Mar 2013 (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.
The purpose of this study is to compare the response to aspirin in the acute phase with the late phase of an acute coronary syndrome.
Detailed description
The purpose of this study is to compare, in the same population, the response to aspirin in the initial phase (first 48 hours) with the late phase (after 3 months of discharge)of a non ST elevation acute coronary syndrome (angina or acute myocardial infarction).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First 48 hours | – | –Patients in the first 48 hours of non ST-elevation acute coronary syndromes. |
| 3 months after discharge | – | –Patients with 3 months after hospital discharge for non ST-elevation acute coronary syndromes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 patients diagnosed with non ST acute coronary syndrome (unstable angina and myocardial infarction without ST elevation), with up to 48 hours of evolution from the onset of symptoms.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Confirmed diagnosis of acute coronary syndrome without ST segment elevation, in the first 48 hours after the onset of the clinical symptoms
- Regular use of aspirin for at least seven days.
Key exclusion criteria (10 listed)
- Previous use, in the last 7 days, of another antiplatelet agent than aspirin
- Use of antivitamin K in the last 3 weeks
- Hemoglobin < 10g/dL and / or hematocrit < 30% or > 50%, platelets count < 100.000/mm3 or > 500.000/mm3, creatinine clearance < 30 mL / minute
- Killip class III or IV
- Need for vasopressor or inotropic parenteral medication at inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare platelet aggregation between the first 48 hours and 3 months after discharge.
Time frame: 3 months
5 secondary outcomes
Relation between platelet aggregability and the composite endpoint of death, myocardial infarction, unstable angina and need for revascularization or hospitalization at 3 months after discharge.
Time frame: 3 months
Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours.
Time frame: 48 hours
Relation between C reactive protein and interleukin -6 with levels of platelet aggregation.
Time frame: first 48 hours and 3 months
Relation between platelet aggregation and the presence or absence of selected polymorphisms.
Time frame: first 48 hours and 3 months
Platelet aggregation in respect to age, gender, glucose at hospital arrival, glycated hemoglobin, statin, PPI, current smokers, ACE inhibitors, type of ACS presentation.
Time frame: first 48 hours and 3 months
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 28 Mar 2013.
- Related InfoLink provided by the sponsor.
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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.
Jose C Nicolau, MD, PhD study chair
Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Non ST-elevation Acute Coronary Syndromes, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 10 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 28 Mar 2013. 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 Brazil. 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.
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?
Compare platelet aggregation between the first 48 hours and 3 months after discharge. (time frame: 3 months). 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 28 Mar 2013.