Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02316119
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2014-12-03
Brief Title:
Mechanistic Study of Bleeding Risk in Coronary Patients With Cerebrovascular Disease
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ISTIA previously to the acute coronary event Case Group and 100 patients without ISTIA 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None