Skip to main content
OpenTrials
Completed

NCT Number: NCT02316119

Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)

    Time frame: in the selection visit

Secondary outcomes

  1. Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)

    Time frame: in the selection visit

Other outcomes

  1. light transmission aggregometry with ADP (maximum amplitude)

    Time frame: in the selection visit

  2. light transmission aggregometry with epinephrine (maximum amplitude)

    Time frame: in the selection visit

  3. platelet acitivity by PFA 100® (seconds)

    Time frame: in the selection visit

  4. kinetics of clot by thromboelastography usin Reorox ® (seconds, paschal/min, paschal)

    Time frame: in the selection visit

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

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 12, 2014
Registry last updated
Apr 26, 2016

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.

Published trials that share one or more normalized conditions with this study.