Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

April 25, 2016 updated by: University of Sao Paulo General Hospital

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403000
        • Clinical unit of acute coronary disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Post-ACS patients and taking aspirin

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Post-ACS patients without history of IS/TIA previously to the acute coronary and taking aspirin
Case group
Post ACS patients with history of IS/TIA previously to the acute coronary event and taking aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)
Time Frame: in the selection visit
in the selection visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)
Time Frame: in the selection visit
in the selection visit

Other Outcome Measures

Outcome Measure
Time Frame
light transmission aggregometry with ADP (maximum amplitude)
Time Frame: in the selection visit
in the selection visit
light transmission aggregometry with epinephrine (maximum amplitude)
Time Frame: in the selection visit
in the selection visit
platelet acitivity by PFA 100® (seconds)
Time Frame: in the selection visit
in the selection visit
kinetics of clot by thromboelastography usin Reorox ® (seconds, paschal/min, paschal)
Time Frame: in the selection visit
in the selection visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Estimate)

April 26, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPESP2012/04930-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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