Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease

Completed

• Conditions: Coronary Heart Disease; Non ST-elevation Acute Coronary Syndromes

• Registration Number: NCT01820429
• Lead Sponsor: University of Sao Paulo General Hospital

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).

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-02
• Study Completion: 2012-04
• Study First Submitted: 2012-07-10
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-25
• Last Update Submitted: 2013-03-25
• Study First Posted: 2013-03-28
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare platelet aggregation between the first 48 hours and 3 months after discharge.	3 months

Secondary Outcome Measures

Name	Time	Method
Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours.	48 hours
Relation between C reactive protein and interleukin -6 with levels of platelet aggregation.	first 48 hours and 3 months
Relation between platelet aggregation and the presence or absence of selected polymorphisms.	first 48 hours and 3 months
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.	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.	first 48 hours and 3 months	Cut point for age 65 y, for glycemia 125 mg/dL, for glycated hemoglobin 6%

Trial Locations

Locations (1)

Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School; 🇧🇷 São Paulo, Brazil