Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

Completed

• Conditions: Cerebral Stroke; Coronary Artery Disease; TIA (Transient Ischemic Attack)

• Registration Number: NCT02316119
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-06
• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-12
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)	in the selection visit

Secondary Outcome Measures

Name	Time	Method
Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)	in the selection visit

Trial Locations

Locations (1)

Clinical unit of acute coronary disease; 🇧🇷 São Paulo, Brazil