Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316119
• Other study ID #: FAPESP2012/04930-0
• Status: Completed
• Phase: N/A
• First received: December 3, 2014
• Last updated: April 25, 2016
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: June 2014
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Stroke
• Coronary Artery Disease
• Coronary Disease
• Ischemic Attack, Transient
• Myocardial Ischemia
• Stroke
• TIA (Transient Ischemic Attack)

Locations

Country	Name	City	State
Brazil	Clinical unit of acute coronary disease	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	light transmission aggregometry with ADP (maximum amplitude)		in the selection visit	No
Other	light transmission aggregometry with epinephrine (maximum amplitude)		in the selection visit	No
Other	platelet acitivity by PFA 100® (seconds)		in the selection visit	No
Other	kinetics of clot by thromboelastography usin Reorox ® (seconds, paschal/min, paschal)		in the selection visit	No
Primary	Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)		in the selection visit	No
Secondary	Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)		in the selection visit	No