Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-18 @ 2:46 PM
Study NCT ID:
NCT02516267
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2015-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Platelet Aggregability in the Release of CABG in Patients With ACS With DAPT.
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
The Importance of Evaluation of Platelet Aggregability in the Release of Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome With Dual Antiplatelet Therapy.
Status:
COMPLETED
Status Verified Date:
2020-03
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:
The purpose of this study is to assess platelet aggregability by a "point of care" device (Multiplate®) to decrease the release time for coronary artery bypass graft (CABG ) in patients with acute coronary syndrome (ACS) in use of dual antiplatelet therapy.
Detailed Description:
This open, prospective, randomized study will be included patients with acute coronary syndrome (ACS) and coronary artery bypass graft (CABG) indication in use of double platelet aggregation (aspirin and inhibitor of ADP). The groups to be analyzed will be:
1. Control group: It is composed of patients who will discontinue inhibitor of ADP for 5 days before surgery, and must be operated on the first working day after completing the 5 days without the drug. This group will have aggregability evaluated by platelet function testing (Multiplate®) immediately before the transport to the operating room.
2. Intervention group: It is composed of patients who will be evaluated by platelet function testing (Multiplate®) daily until the value obtained\> 46 AU, when they will be immediately released to CABG, to be held on the first working day after release.
All patients included, after the explanations and signing the informed consent, will initially undergo preoperative examinations as institutional routine. In the immediate period (24 hours) after CABG will be collected on all results of tests to which the patient is submitted in accordance with the institutional routines, and the volume of chest tube bleeding and need for blood transfusions. Clinical data "MACE" will be collected throughout the patient's hospital stay.
1. Control group: It is composed of patients who will discontinue inhibitor of ADP for 5 days before surgery, and must be operated on the first working day after completing the 5 days without the drug. This group will have aggregability evaluated by platelet function testing (Multiplate®) immediately before the transport to the operating room.
2. Intervention group: It is composed of patients who will be evaluated by platelet function testing (Multiplate®) daily until the value obtained\> 46 AU, when they will be immediately released to CABG, to be held on the first working day after release.
All patients included, after the explanations and signing the informed consent, will initially undergo preoperative examinations as institutional routine. In the immediate period (24 hours) after CABG will be collected on all results of tests to which the patient is submitted in accordance with the institutional routines, and the volume of chest tube bleeding and need for blood transfusions. Clinical data "MACE" will be collected throughout the patient's hospital stay.
Study Oversight
Has Oversight DMC:
True
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?: