Evaluation of Platelet Aggregability in the Release of CABG in Patients With ACS With DAPT.

NCT02516267 | Completed DMC

• 1 other identifier: Multiplate CABG
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding

Keywords

platelet aggregability; acute coronary syndrome; coronary artery bypass graft

Outcome Measures

Primary Outcomes (1)

• Bleeding by chest tubes in 24 hours postoperative.

  24 hours postoperative.

Study Arms (2)

Control Group

NO INTERVENTION

Patients who will discontinue inhibitor-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 its aggregability evaluated by platelet function testing (Multiplate ADP®) immediately before the transport to the operating room.

Intervention Group

ACTIVE COMPARATOR

Patients will be evaluated by platelet function testing (Multiplate ADP®) 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.

Device: Multiplate ADP®

Interventions

Multiplate ADP® DEVICE

Patients will be evaluated by platelet function testing (Multiplate ADP®) daily until the value obtained\> 46 AU, when they will be immediately released to CABG

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Age\> 18 years;
• Hospitalization for ACS defined as:
• \- Symptoms ischemic unstable pattern, occurring at rest or upon exertion within 72 hours of an unscheduled hospitalization, related to presumed or proven coronary artery, and at least one of the following:
• elevated cardiac biomarkers (troponin I or CK-MB mass) above the 99th percentile.
• Changes in resting electrocardiogram compatible with ischemia or infarction and further evidence of obstructive coronary artery disease:
• the resting ECG compatible with ischemia or infarction in at least one of the criteria below:
• ST segment depression of new or presumably new\> 0.5 mm in 2 sequential leads.
• The new ST-segment elevation or presumed new J point in two contínguas leads with value\> 0.2mV in men or\> 0.15mV in women in V2-V3 and / or\> 0.1mV in other leads or new left bundle branch block or presumably again.
• T wave inversion new or presumably new\> 1mm in leads with a broad R wave in two contiguous leads.
• New pathological Q wave or presumably new\> 30 ms duration and\> 1mm deep in 2 contiguous leads or\> 20 ms or QS complex in V2 and V3.
• Peaked new R Wave\> 40 ms in V1 and V2, R / S\> 1 in V1 with positive T wave in the absence of consistent driving change.
• Additional evidence of coronary artery disease in at least one of the criteria below:
• Evidence of myocardial ischemia or new or presumably new in imaging with perfusion.
• Contractility Change in new or presumably new wall.
• Coronary angiography with obstruction\> 70% in epicardial coronary artery.

You may not qualify if:

• anemia (hematocrit \<30%).
• Thrombocytopenia (\<100,000 / mm³).
• Coagulopathy (history of bleeding diathesis or use of oral anticoagulants).
• Chronic renal failure dialysis or creatinine clearance \<30 ml / min / m2 (estimated by MDRD formula).
• Active liver disease.
• combined valvuloplasty or valve replacement surgery ..
• Angioplasty with stent for less than 30 days or with drug-eluting stents for less than one year.
• Use of fibrinolytic specific fibrin not less than 48 hours or specific fibrin less than 24 hours of randomization;
• Any medical condition that in the investigator's opinion present significant risk to the patient or interfere with the interpretation of the safety and efficacy;
• Patients who are taking part in another clinical study.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Carlos Alberto Kenji Nakashima

São Paulo, 05409002, Brazil

Location

Related Publications (1)

• Nakashima CAK, Dallan LAO, Lisboa LAF, Jatene FB, Hajjar LA, Soeiro AM, Furtado RHM, Dalcoquio TF, Baracioli LM, Lima FG, Giraldez RRCV, Silva BA, Costa MSS, Strunz CMC, Dallan LRP, Barbosa CJDG, Britto FAB, Farkouh ME, Gurbel PA, Nicolau JC. Platelet Reactivity in Patients With Acute Coronary Syndromes Awaiting Surgical Revascularization. J Am Coll Cardiol. 2021 Mar 16;77(10):1277-1286. doi: 10.1016/j.jacc.2021.01.015.

  PMID: 33706868 DERIVED

MeSH Terms

Conditions

Hemorrhage; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jose Carlos Nicolau, Cardiology

  Heart Institute (HC/FMUSP)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 5, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: January 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

BR (1)