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Completed

NCT Number: NCT01820429

Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

São Paulo, 05403900, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Compare platelet aggregation between the first 48 hours and 3 months after discharge.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 3 months

  2. Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours.

    Time frame: 48 hours

  3. Relation between C reactive protein and interleukin -6 with levels of platelet aggregation.

    Time frame: first 48 hours and 3 months

  4. Relation between platelet aggregation and the presence or absence of selected polymorphisms.

    Time frame: first 48 hours and 3 months

  5. Platelet aggregation in respect to age, gender, glucose at hospital arrival, glycated hemoglobin, statin, PPI, current smokers, ACE inhibitors, type of ACS presentation.

    Time frame: first 48 hours and 3 months

    Cut point for age 65 y, for glycemia 125 mg/dL, for glycated hemoglobin 6%

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 28, 2013
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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