Clinical trial NCT02316119: Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Cerebral Stroke
TIA (Transient Ischemic Attack)
Keywords: bleeding risk, acute coronary syndrome, platelet agregation,
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-12-12
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-ACS patients and taking aspirin

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


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

Primary outcomes:
measure: Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)
timeFrame: in the selection visit
Secondary outcomes:
measure: Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)
timeFrame: in the selection visit
Other outcomes:
measure: light transmission aggregometry with ADP (maximum amplitude)
timeFrame: in the selection visit
measure: light transmission aggregometry with epinephrine (maximum amplitude)
timeFrame: in the selection visit
measure: platelet acitivity by PFA 100® (seconds)
timeFrame: in the selection visit
measure: kinetics of clot by thromboelastography usin Reorox ® (seconds, paschal/min, paschal)
timeFrame: in the selection visit
Locations:
city: São Paulo
country: Brazil
facility: Clinical unit of acute coronary disease
Study officials:
References: