BleedingNCT02516267
Evaluation of Platelet Aggregability in the Release of CABG in Patients With ACS With DAPT.
A study testing Multiplate ADP® in people with Bleeding, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding
- What is being tested?
- Multiplate ADP®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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);
Who cannot join
- 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 ..
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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:
- 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.
- Conditions
- Bleeding
- Being tested
- Multiplate ADP®
- Keywords
- platelet aggregability, acute coronary syndrome, coronary artery bypass graft
- Medical subject headings
- Hemorrhage, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Multiplate ADP® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding by chest tubes in 24 hours postoperative.
Measured: 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2015
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Alberto Kenji Nakashima, University of Sao Paulo General Hospital
- Investigators
- Jose Carlos Nicolau, Cardiology, Study chair, Heart Institute (HC/FMUSP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516267
- Sponsor's protocol ID
- Multiplate CABG
- Status last verified
- Mar 2020
- First submitted
- 3 Aug 2015
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02516267
- Acronym / sponsor ID
- Multiplate CABG
- Conditions
- Bleeding
- Keywords
- platelet aggregability, acute coronary syndrome, coronary artery bypass graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Multiplate 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, to be held on the first working day after release. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age> 18 years;
- Hospitalization for ACS defined as:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplate 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 | Device | Intervention Group |
Primary outcome
Bleeding by chest tubes in 24 hours postoperative.
Time frame: 24 hours postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 33706868Nakashima 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Carlos Nicolau, Cardiology study chair
Heart Institute (HC/FMUSP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiplate ADP® in people with Bleeding, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding by chest tubes in 24 hours postoperative. (time frame: 24 hours postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02516267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.