Clinical trial NCT01820429: Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease
Official title: Residual Platelet Activity Despite Aspirin Utilization in Patients With Non ST Elevation Acute Coronary Syndromes: Comparison Between the Acute and Chronic Phases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Non ST-elevation Acute Coronary Syndromes
Keywords: Platelet aggregation
Aspirin
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2013-03-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Compare platelet aggregation between the first 48 hours and 3 months after discharge.
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 3 months
measure: Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours.
timeFrame: 48 hours
measure: Relation between C reactive protein and interleukin -6 with levels of platelet aggregation.
timeFrame: first 48 hours and 3 months
measure: Relation between platelet aggregation and the presence or absence of selected polymorphisms.
timeFrame: first 48 hours and 3 months
measure: Platelet aggregation in respect to age, gender, glucose at hospital arrival, glycated hemoglobin, statin, PPI, current smokers, ACE inhibitors, type of ACS presentation.
timeFrame: first 48 hours and 3 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School
Study officials:
affiliation: Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School
name: Jose C Nicolau, MD, PhD
role: STUDY_CHAIR
References: