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Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02316119
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
140
Enrollment
1
Location
39
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    140 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Mechanisms Involved in the Bleeding Risk of Patients With Coronary Artery Diseased Previous Stroke or Transient Ischemic Attack in Use of Antiplatelet Therapy
    Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Apr 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units) [in the selection visit]

    Secondary Outcome Measures

    1. Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units) [in the selection visit]

    Other Outcome Measures

    1. light transmission aggregometry with ADP (maximum amplitude) [in the selection visit]

    2. light transmission aggregometry with epinephrine (maximum amplitude) [in the selection visit]

    3. platelet acitivity by PFA 100® (seconds) [in the selection visit]

    4. kinetics of clot by thromboelastography usin Reorox ® (seconds, paschal/min, paschal) [in the selection visit]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical unit of acute coronary disease São Paulo Brazil 05403000

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital
    • Fundação de Amparo à Pesquisa do Estado de São Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT02316119
    Other Study ID Numbers:
    • FAPESP2012/04930-0
    First Posted:
    Dec 12, 2014
    Last Update Posted:
    Apr 26, 2016
    Last Verified:
    Jun 1, 2014
    Keywords provided by University of Sao Paulo General Hospital
    bleeding risk, acute coronary syndrome, platelet agregation,
    Additional relevant MeSH terms:
    Stroke
    Ischemic Attack, Transient
    Coronary Artery Disease
    Hemorrhage

    Study Results

    No Results Posted as of Apr 26, 2016