Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403900
    • Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compare platelet aggregation between the first 48 hours and 3 months after discharge.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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%	first 48 hours and 3 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Chair: Jose C Nicolau, MD, PhD, Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): March 28, 2013
• Last Update Submitted That Met QC Criteria: March 25, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Aspirin; Platelet aggregation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: INCORPA