A Phase 4 interventional study of Paracetamol and Fentanyl in STEMI and STEMI - ST Elevation Myocardial Infarction, sponsored by A.H. Tavenier. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by A.H. Tavenier · Phase 4, Interventional, and Treatment
Fast and accurate platelet inhibition is an important therapeutic goal in the acute treatment of patients with ST-segment elevation myocardial infarction (STEMI). Platelet inhibitory effects induced by normal oral P2Y12 receptor antagonists, for example ticagrelor, are delayed in STEMI patients undergoing primary percutaneous coronary intervention (primary PCI), which may be attributed to impaired absorption affecting drug pharmacokinetics (PK) and pharmacodynamics (PD). Another therapeutic goal in the acute treatment of STEMI is reduction of sympathetic stress and catecholamine release, thereby improving the balance between the demand for and supply of oxygen, by analgesia like fentanyl of morphine. To date, there are no studies that have specifically assessed the pharmacodynamics influences of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor tablets. Therefore, In the ON-TIME-3 study, the investigators seek to show the influence of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance.
850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.
This study's enrollment of 200 is close to the median of 194 across 527 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →This is the only study on the registry with A.H. Tavenier as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
i. age ≥18 years
ii. referred by ambulance paramedics to Isala (Zwolle) or Zuyderland Hospital (Heerlen)
iii. diagnosed in the ambulance with STEMI defined as:
iv. ongoing chest pain with a pain score (NRS) ≥4
v. the patient has been informed of the nature of the study, agrees to its provisions and has provided verbal in the pre-hospital phase followed by written informed consent in hospital
Exclusion Criteria:
i. presenting with cardiogenic shock; defined as:
ii. patients with a nasogastric tube in situ or requiring a nasogastric tube
iii. patients who already received fentanyl or paracetamol \<2 hours prior to randomization
iv. patients on current treatment with P2Y12 inhibitors (ticagrelor, clopidogrel or prasugrel)
v. allergy to morphine or paracetamol
vi. patients with recent major bleeding complications or to dual antiplatelet therapy:
vii. received any organ transplant or is on a waiting list for any organ transplant
viii. patients undergoing dialysis
ix. pregnant or lactating female
x. patients currently participating in another drug or device study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
Drug: Paracetamol
Drug: Fentanyl
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
platelet reactivity
Platelet reactivity units (PRU) directly post-PCI or 1 hour post-angiography
Time frame: directly post-PCI or 1 hour post-angiography
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Oct 2019, 20 months.
Of 44 non-industry phase 4 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 74. This study's 20 months is below that.
Counting every sponsor, half of 49 studies reached it within 34 months; a quarter within 22 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetaminophen · Fentanyl
ST Elevation Myocardial Infarction →