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

Primary Purpose

Bleeding

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Multiplate ADP®

About this trial

This is an interventional diagnostic trial for Bleeding focused on measuring platelet aggregability, acute coronary syndrome, coronary artery bypass graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Use of dual antiplatelet therapy (ASA associated with P2Y12 receptor inhibitor);
An indication of CABG.
Agreement to sign the Informed Consent (IC);

Exclusion criteria:

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.

Sites / Locations

Carlos Alberto Kenji Nakashima

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Bleeding by chest tubes in 24 hours postoperative.

Secondary Outcome Measures

Full Information

NCT ID

NCT02516267

First Posted

August 3, 2015

Last Updated

March 23, 2020

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02516267

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bleeding

Keywords

platelet aggregability, acute coronary syndrome, coronary artery bypass graft

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

190 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Arm Title

Intervention Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Multiplate ADP®

Intervention Description

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

Primary Outcome Measure Information:

Title

Bleeding by chest tubes in 24 hours postoperative.

Time Frame

24 hours postoperative.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Use of dual antiplatelet therapy (ASA associated with P2Y12 receptor inhibitor); An indication of CABG. Agreement to sign the Informed Consent (IC); Exclusion criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Carlos Nicolau, Cardiology

Organizational Affiliation

Heart Institute (HC/FMUSP)

Official's Role

Study Chair

Facility Information:

Facility Name

Carlos Alberto Kenji Nakashima

City

Sao Paulo

ZIP/Postal Code

05409002

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

33706868

Citation

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.

Results Reference

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

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