Isala clinics
Zwolle, Netherlands
NCT Number: NCT03400267
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Zwolle, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 informed consent 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 contraindication 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 investigational drug or device study
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.
Time frame: directly post-PCI or 1 hour post-angiography
Platelet reactivity units (PRU) directly post-PCI or 1 hour post-angiography
A.H. Tavenier
Other
Acronym: ON-TIME 3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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