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Clinical Trials/NCT02316119
NCT02316119
Completed
N/A

Mechanisms Involved in the Bleeding Risk of Patients With Coronary Artery Diseased Previous Stroke or Transient Ischemic Attack in Use of Antiplatelet Therapy

University of Sao Paulo General Hospital1 site in 1 country140 target enrollmentJanuary 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Sao Paulo General Hospital
Enrollment
140
Locations
1
Primary Endpoint
Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Background: About 5% of patients with acute coronary syndrome (ACS) have had previously ischemic stroke (IS) or transitory ischemic attack (TIA). This is a high-risk population, with a high incidence of ischemic events, and also of bleeding events. While the high ischemic risk in this population is attributed to a higher prevalence of cardiovascular risk factors, their predisposition to bleeding events is not well understood. Hypothesis: The increased bleeding risk in ACS patients with history of cerebrovascular event may be justified by a low platelet activity. Methods: Unicentric, prospective, case-control study, which included approximately 100 post-ACS patients with history of IS/TIA previously to the acute coronary event (Case Group) and 100 patients without IS/TIA (Control group). The groups were matched for gender, age, and ACS type and year of occurrence. All patients were taking aspirin, and the main exclusion criteria were use of dual antiplatelet therapy, previous hemorrhagic stroke, severe renal dysfunction, thrombocytopenia or coagulopathy. Main analysis: Platelet aggregation was evaluated by 6 methods: VerifyNow Aspirin®, VerifyNow P2Y12®, PFA 100®, thrombelastography (ReoRox®), light transmission aggregometry with ADP (LTA ADP) and epinephrine (LTA EPI) as agonists. Additional analysis: genetic, HDL transport and inflammatory evaliation

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
April 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Post-ACS patients with history of IS/TIA previously to the acute coronary event and taking aspirin
  • Sign the consent form

Exclusion Criteria

  • Hemorrhagic stroke
  • Another antiplatelet drug than aspirin
  • Use of Anti inflammatory drug
  • Severe chronic kidney dysfunction
  • Liver disease
  • Coagulopathy
  • Platelet disfunction
  • Thrombocytopenia or thrombocytosis
  • Refuse to sign the consent form

Outcomes

Primary Outcomes

Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)

Time Frame: in the selection visit

Secondary Outcomes

  • Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)(in the selection visit)

Study Sites (1)

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