Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease

Coronary Heart Disease Clinical Trial

Official title:

Residual Platelet Activity Despite Aspirin Utilization in Patients With Non ST Elevation Acute Coronary Syndromes: Comparison Between the Acute and Chronic Phases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820429
• Other study ID #: INCORPA
• Status: Completed
• Phase: N/A
• First received: July 10, 2012
• Last updated: March 25, 2013
• Start date: December 2009
• Est. completion date: April 2012

Study information

• Verified date: March 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Non ST-elevation Acute Coronary Syndromes

Locations

Country	Name	City	State
Brazil	Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare platelet aggregation between the first 48 hours and 3 months after discharge.		3 months	No
Secondary	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	No
Secondary	Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours.		48 hours	No
Secondary	Relation between C reactive protein and interleukin -6 with levels of platelet aggregation.		first 48 hours and 3 months	No
Secondary	Relation between platelet aggregation and the presence or absence of selected polymorphisms.		first 48 hours and 3 months	No
Secondary	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	No

External Links

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