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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding by chest tubes in 24 hours postoperative. | 24 hours postoperative. |
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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:
the resting ECG compatible with ischemia or infarction in at least one of the criteria below:
Use of dual antiplatelet therapy (ASA associated with P2Y12 receptor inhibitor);
An indication of CABG.
Agreement to sign the Informed Consent (IC);
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Carlos Nicolau, Cardiology | Heart Institute (HC/FMUSP) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carlos Alberto Kenji Nakashima | São Paulo | 05409002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33706868 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 30, 2024 | |
| Reset | Jul 18, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 30, 2024 | Jul 18, 2024 |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |