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CompletedNCT02516267Updated Mar 24, 2020

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

An interventional study of Multiplate ADP® in Bleeding, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-24.

Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bleeding

Keywords

  • platelet aggregability
  • acute coronary syndrome
  • coronary artery bypass graft
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 190 is close to the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age> 18 years;
  2. 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.
  3. Use of dual antiplatelet therapy (ASA associated with P2Y12 receptor inhibitor);
  4. An indication of CABG.
  5. Agreement to sign the Informed Consent (IC);

Exclusion criteria

Exclusion criteria:

  1. anemia (hematocrit \<30%).
  2. Thrombocytopenia (\<100,000 / mm³).
  3. Coagulopathy (history of bleeding diathesis or use of oral anticoagulants).
  4. Chronic renal failure dialysis or creatinine clearance \<30 ml / min / m2 (estimated by MDRD formula).
  5. Active liver disease.
  6. combined valvuloplasty or valve replacement surgery ..
  7. Angioplasty with stent for less than 30 days or with drug-eluting stents for less than one year.
  8. Use of fibrinolytic specific fibrin not less than 48 hours or specific fibrin less than 24 hours of randomization;
  9. 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;
  10. Patients who are taking part in another clinical study.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
190 participants (actual)

Study arms

  • No intervention
    Control Group

    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.

  • Active comparator
    Intervention Group

    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

  • DeviceMultiplate ADP®

    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

06

What researchers measure

Primary outcomes

  1. Bleeding by chest tubes in 24 hours postoperative.

    Time frame: 24 hours postoperative.

07

Study locations

1 site
  • Carlos Alberto Kenji Nakashima
    Sao Paulo, 05409002, Brazil
08

References and documents

Publications

  • 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. PubMed 33706868 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02516267
Lead sponsor
University of Sao Paulo General Hospital
Responsible party
Carlos Alberto Kenji Nakashima (Medical Doctor, University of Sao Paulo General Hospital) — Principal investigator
First posted
Aug 5, 2015
Start date
Jul 2015
Primary completion
Jul 2015
Completion
Jan 2019
Last update
Mar 24, 2020

Study contacts

Jose Carlos Nicolau, Cardiology
study chair · Heart Institute (HC/FMUSP)

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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