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Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

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ClinicalTrials.gov Identifier: NCT02316119
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : April 26, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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
Coronary Artery Disease Cerebral Stroke TIA (Transient Ischemic Attack)

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 : January 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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



Primary Outcome Measures :
  1. Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units) [ Time Frame: in the selection visit ]

Secondary Outcome Measures :
  1. Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units) [ Time Frame: in the selection visit ]

Other Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post-ACS patients and taking aspirin
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316119


Locations
Brazil
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

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02316119     History of Changes
Other Study ID Numbers: FAPESP2012/04930-0
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: June 2014

Keywords provided by University of Sao Paulo General Hospital:
bleeding risk, acute coronary syndrome, platelet agregation,

Additional relevant MeSH terms:
Stroke
Ischemia
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hemorrhage
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Brain Ischemia