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Residual Platelet Activity Despite Aspirin Utilization in Coronary Heart Disease

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01820429
First received: July 10, 2012
Last updated: March 25, 2013
Last verified: March 2013

July 10, 2012
March 25, 2013
December 2009
February 2012   (final data collection date for primary outcome measure)
Compare platelet aggregation between the first 48 hours and 3 months after discharge. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01820429 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Relation between the atherosclerotic burden by coronary angiography with the platelet aggregation in the first 48 hours. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Relation between C reactive protein and interleukin -6 with levels of platelet aggregation. [ Time Frame: first 48 hours and 3 months ] [ Designated as safety issue: No ]
  • Relation between platelet aggregation and the presence or absence of selected polymorphisms. [ Time Frame: first 48 hours and 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Cut point for age 65 y, for glycemia 125 mg/dL, for glycated hemoglobin 6%
Same as current
Not Provided
Not Provided
 
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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Coronary Heart Disease
  • Non ST-elevation Acute Coronary Syndromes
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01820429
INCORPA
Yes
University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Chair: Jose C Nicolau, MD, PhD Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School
University of Sao Paulo General Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP