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
  Purpose

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.


Condition
Coronary Heart Disease
Non ST-elevation Acute Coronary Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Residual Platelet Activity Despite Aspirin Utilization in Patients With Non ST Elevation Acute Coronary Syndromes: Comparison Between the Acute and Chronic Phases

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Compare platelet aggregation between the first 48 hours and 3 months after discharge. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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%


Enrollment: 70
Study Start Date: December 2009
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01820429

Locations
Brazil
Instituto do Coração (Heart Institute) - Clinical Hospitals, University of São Paulo Medical School
São Paulo, Brazil, 05403900
Sponsors and Collaborators
University of Sao Paulo General Hospital
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
  More Information

Additional Information:
No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01820429     History of Changes
Other Study ID Numbers: INCORPA
Study First Received: July 10, 2012
Last Updated: March 25, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Platelet aggregation
Aspirin

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014