Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease

NCT02316119 | Completed

• 1 other identifier: FAPESP2012/04930-0
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

bleeding risk, acute coronary syndrome, platelet agregation,

Outcome Measures

Primary Outcomes (1)

• Residual platelet activity by VerifyNow Aspirin (Aspirin reactivity units)

  in the selection visit

Secondary Outcomes (1)

• Baseline platelet activity by VerifyNow P2Y12 (P2Y12 reactivity units)

  in the selection visit

Other Outcomes (4)

• light transmission aggregometry with ADP (maximum amplitude)

  in the selection visit

• light transmission aggregometry with epinephrine (maximum amplitude)

  in the selection visit

• platelet acitivity by PFA 100® (seconds)

  in the selection visit

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-ACS patients and taking aspirin

You may qualify if:

• Post-ACS patients with history of IS/TIA previously to the acute coronary event and taking aspirin
• Sign the consent form

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Clinical unit of acute coronary disease

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease; Stroke; Ischemic Attack, Transient; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 12, 2014
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: April 26, 2016

Record last verified: 2014-06

Locations

BR (1)