Cardiac ArrestPLT-ECMONCT05730114
Monitoring Antiplatelet Drugs in Cardiac Arrest Patients
An observational study of Cardiac Arrest and Myocardial Infarction, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Dual Antiplatelet Therapy (DAPT) with acetylsalicylic acid (ASA) and oral P2Y12 inhibitor (Clopidogrel, Ticagrelor or Prasugrel) is recommended in STEMI or NSTEMI patients undergoing primary Percutaneous Coronary Intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Myocardial Infarction, Extracorporeal Membrane Oxygenation
- What is being tested?
- Antiplatelet Drug
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 30 Oct 2024
- Phase
- Observational
- 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
Study population: Patient admitted to ICU for Acute Coronary Syndrome and treated with oral P2Y12 inhibitors during primary PCI.
Who may be able to join
- Patients P2Y12 naive
- Suffering from Acute Coronary Syndrome needing primary percutaneous coronary intervention (PCI) and treated with oral antiP2Y12 drugs
Who cannot join
- Known liver or hematological disease
- Anticoagulant therapy
- Active bleeding needing blood transfusions.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Gerardo dei Tintori
Monza, MB, 20900
Matteo Pozzi, 3477252346, mateo.pozzi@gmail.com
About this study
Official title: Platelet Aggregation in Patients Treated With P2Y12 Inhibitors and V-A ECMO for Cardiac Arrest
Dual Antiplatelet Therapy (DAPT) with acetylsalicylic acid (ASA) and oral P2Y12 inhibitor (Clopidogrel, Ticagrelor or Prasugrel) is recommended in STEMI or NSTEMI patients undergoing primary Percutaneous Coronary Intervention (PCI). There is evidence for an increased risk of stent thrombosis after PCI despite administration of DAPT in patients resuscitated from a cardiac arrest with STEMI/NSTEMI who undergo primary PCI, in particular for those treated with hypothermia. Point of Care Aggregometry represents an emerging tool to measure platelet reactivity in patient treated with antiplatelets drugs. Among patients with Acute Coronary Syndrome (ACS), those requiring Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for refractory Cardiogenic Shock or Cardiac Arrest represent a growing population burdened by more profound metabolic, pharmacokinetic, hemostatic and physiological alterations due to increased clinical severity and ECMO itself. In addition, profound platelet inhibition can result in a higher risk of bleeding complication, since these patients have to be simultaneously anticoagulated with unfractioned heparin (UFH) and ECMO itself can cause coagulopathy. We aimed to perform an observational prospective cohort study to investigate platelet reactivity in a population of ACS patients with different clinical severity.
- Conditions
- Cardiac Arrest, Myocardial Infarction, Extracorporeal Membrane Oxygenation, Platelet Dysfunction
- Being tested
- Antiplatelet Drug
- Medical subject headings
- Heart Arrest, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet DrugDrug
anti-P2Y12 oral agent administered during primary percutaneous coronary intervention.
| Study group | Role | What they receive |
|---|---|---|
| OHCA/ECMO | Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and on VA-ECMO. Receives: Drug: Antiplatelet Drug | |
| OHCA/nonECMO | Patient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO. Receives: Drug: Antiplatelet Drug | |
| nonOHCA/nonECMO | Patient with acute coronary syndrome without Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO. Receives: Drug: Antiplatelet Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRPR risk
Relative risk to develop High Residual Platelet Reactivity (HRPR) during the first seven days of treatment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Oct 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Pozzi, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730114
- Sponsor's protocol ID
- 3940
- Acronym
- PLT-ECMO
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Aggregation in Patients Treated With P2Y12 Inhibitors and V-A ECMO for Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05730114
- Acronym / sponsor ID
- PLT-ECMO / 3940
- Conditions
- Cardiac Arrest, Myocardial Infarction, Extracorporeal Membrane Oxygenation, Platelet Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 15 Feb 2023 (actual)
- 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.
Dual Antiplatelet Therapy (DAPT) with acetylsalicylic acid (ASA) and oral P2Y12 inhibitor (Clopidogrel, Ticagrelor or Prasugrel) is recommended in STEMI or NSTEMI patients undergoing primary Percutaneous Coronary Intervention (PCI). There is evidence for an increased risk of stent thrombosis after PCI despite administration of DAPT in patients resuscitated from a cardiac arrest with STEMI/NSTEMI who undergo primary PCI, in particular for those treated with hypothermia. Point of Care Aggregometry represents an emerging tool to measure platelet reactivity in patient treated with antiplatelets drugs. Among patients with Acute Coronary Syndrome (ACS), those requiring Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for refractory Cardiogenic Shock or Cardiac Arrest represent a growing population burdened by more profound metabolic, pharmacokinetic, hemostatic and physiological alterations due to increased clinical severity and ECMO itself. In addition, profound platelet inhibition can result in a higher risk of bleeding complication, since these patients have to be simultaneously anticoagulated with unfractioned heparin (UFH) and ECMO itself can cause coagulopathy. We aimed to perform an observational prospective cohort study to investigate platelet reactivity in a population of ACS patients with different clinical severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OHCA/ECMO | – | Drug: Antiplatelet DrugPatient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and on VA-ECMO. |
| OHCA/nonECMO | – | Drug: Antiplatelet DrugPatient resuscitated from Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO. |
| nonOHCA/nonECMO | – | Drug: Antiplatelet DrugPatient with acute coronary syndrome without Out of Hospital Cardiac Arrest from acute coronary syndrome and without VA-ECMO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient admitted to ICU for Acute Coronary Syndrome and treated with oral P2Y12 inhibitors during primary PCI.
Key inclusion criteria (2 listed)
- Patients P2Y12 naive
- Suffering from Acute Coronary Syndrome needing primary percutaneous coronary intervention (PCI) and treated with oral antiP2Y12 drugs
Key exclusion criteria (3 listed)
- Known liver or hematological disease
- Anticoagulant therapy
- Active bleeding needing blood transfusions.
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 |
|---|---|---|
| Antiplatelet Druganti-P2Y12 oral agent administered during primary percutaneous coronary intervention. | Drug | OHCA/ECMO, OHCA/nonECMO, nonOHCA/nonECMO |
Primary outcome
HRPR risk
Time frame: 7 days
Relative risk to develop High Residual Platelet Reactivity (HRPR) during the first seven days of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Myocardial Infarction, run by University of Milano Bicocca at 1 site in Italy.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Pozzi, MD (00390392334330, mateo.pozzi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRPR risk (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.