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Het effect van opiaten op de werking van bloedplaatjes (P2Y12 receptor remming) bij patiŽnten met een hartinfarct (ST-Elevation Myocardial Infarction) die vooraf worden behandeld met gemalenTicagrelor


- candidate number27761
- NTR NumberNTR6785
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-aug-2017
- Secondary IDs(CCMO) ABR 62462 NL62462.075.17 
- Public TitleHet effect van opiaten op de werking van bloedplaatjes (P2Y12 receptor remming) bij patiŽnten met een hartinfarct (ST-Elevation Myocardial Infarction) die vooraf worden behandeld met gemalenTicagrelor
- Scientific TitleThe effect of Opioids on P2Y12 Receptor Inhibition in patients with ST-Elevation Myocardial Infarction who are pre-treated with crushed Ticagrelor
- ACRONYMON-TIME-3
- hypothesisThe hypothesis is that STEMI patients who are pre-treated with crushed ticagrelor and paracetamol have a higher level of platelet inhibition after primary PCI than patients pre-treated with crushed ticagrelor who are treated with fentanyl.
- Healt Condition(s) or Problem(s) studiedPercutaneous Coronary Intervention (PCI), ST-Elevation Myocardial Infarction (STEMI), Platelet inhibition, Paracetamol, P2Y12 receptor antagonists, Fentanyl
- Inclusion criteria1. age >17 years
2. referred by ambulance paramedics to Isala (Zwolle) or Zuyderland Hospital (Heerlen)
3. diagnosed in the ambulance with STEMI defined as:
- ongoing chest pain >30 minutes and <12 hours duration and
- ST-segment elevation >0.1 mV in at least 2 contiguous leads
4. ongoing chest pain with a pain score (NRS) °›4
5. 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 criteria1. presenting with cardiogenic shock; defined as:
- systolic blood pressure <90 mmHg and
- heart rate >100/min and
- peripheral oxygen saturation <90% (without oxygen administration)
2. patients with a nasogastric tube in situ or requiring a nasogastric tube
3. patients who already received fentanyl or paracetamol <2 hours prior to randomization
4. patients on current treatment with P2Y12 inhibitors (ticagrelor, clopidogrel or prasugrel)
5. allergy to morphine or paracetamol
6. patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
- hypersensitivity to aspirin or ticagrelor
- current use of (new) oral anticoagulation
- history of bleeding diathesis or known coagulopathy
- refusal of blood transfusions
- history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
- known severe liver dysfunction
7. received any organ transplant or is on a waiting list for any organ transplant
8. patients undergoing dialysis
9. pregnant or lactating female
10. patients currently participating in another investigational drug or device study
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2017
- planned closingdate1-jul-2019
- Target number of participants190
- InterventionsPatients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
- Primary outcomeThe primary endpoint of the study is to show that patients with STEMI who are pre-treated with crushed ticagrelor 180 mg and paracetamol 1000 mg have a higher level of platelet inhibition directly after primary PCI compared to patients pre-treated with crushed ticagrelor 180 mg and fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg. This is measured by the level of platelet reactivity units (PRU) at T2 (directly post-PCI or 1 hour post-angiography.
- Secondary outcomeSecondary endpoints:
- Pain reduction measured by the level of pain using numeric rating score.
- The level of platelet inhibition (PRU) at T1, T3 and T4.
- The percentage of High on treatment Platelet Reactivity (HPR) as defined as a PRU >208 (1) at T1, T2, T3 and T4.
- The level of the active metabolite of a higher active metabolite of ticagrelor and AR-C124910XX measured in plasma, at T1, T2, T3 and T4.
- Extent of ST-segment deviation (°›70% ST- segment resolution) pre-PCI and 1 hour post-PCI.
- TIMI flow grade 3 in the culprit vessel at initial angiography.
- Requiring of fentanyl in patients randomized to paracetamol.
- MACE and stent thrombosis at 30 days of follow-up.
- TimepointsBlood sample measurements for platelet function testing and level of active metabolite of ticagrelor, using Verify Now P2Y12 assay (Accumetrics, San Diego, California), will be done at four time points:
- 1: when arriving at the cathlab
- 2: directly post-primary PCI or 1 hour after coronary angiography when no PCI was performed
- 3: one hour post-primary PCI including electrocardiogram (ECG) or 2 hours post- coronary angiography
- 4: six hours post-primary PCI of 7 hours post-coronary angiography
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES H. Wetering, van de
- CONTACT for SCIENTIFIC QUERIES R.S. Hermanides
- Sponsor/Initiator Isala Zwolle
- Funding
(Source(s) of Monetary or Material Support)
AstraZeneca
- Publications
- Brief summaryBackground of the study:
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 PD influences of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor tablets. Therefore, In the ON-TIME-3 study, we seek to show the influence of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance.

Objective of the study:
Primary Objective: The aim of the study is to show that STEMI patients who are pre-treated with crushed ticagrelor and paracetamol have a higher level of platelet inhibition after primary PCI than patients pre-treated with crushed ticagrelor who are treated with fentanyl.

Study design:
This is a multicenter, prospective, randomized, investigator-initiated open-label study

Study population:
Patients with ongoing chest pain with the diagnosis of STEMI in the ambulance.

Intervention:
Patients are randomized to paracetamol 1000mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.

Primary study parameters/outcome of the study:
The primary endpoint of the study is:
to show that patients with STEMI who are pre-treated with crushed ticagrelor 180 mg and paracetamol 1000 mg have a higher level of platelet inhibition directly after primary PCI compared to patients pre-treated with crushed ticagrelor 180 mg and fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg.
- Main changes (audit trail)
- RECORD22-aug-2017 - 16-nov-2017


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