Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease

NCT ID: NCT01820429

Last Updated: 2013-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-04-30

Brief Summary

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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

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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).

Conditions

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Coronary Heart Disease Non ST-elevation Acute Coronary Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First 48 hours

Patients in the first 48 hours of non ST-elevation acute coronary syndromes.

No interventions assigned to this group

3 months after discharge

Patients with 3 months after hospital discharge for non ST-elevation acute coronary syndromes.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose C Nicolau, MD, PhD

Role: STUDY_CHAIR

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

Locations

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

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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INCORPA

Identifier Type: -

Identifier Source: org_study_id

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