NCT03400267

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 16, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.7 years

First QC Date

October 30, 2017

Last Update Submit

February 11, 2020

Conditions

STEMISTEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • platelet reactivity

    Platelet reactivity units (PRU) directly post-PCI or 1 hour post-angiography

    directly post-PCI or 1 hour post-angiography

Study Arms (2)

paracetamol

ACTIVE COMPARATOR

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

Drug: Paracetamol

fentanyl

ACTIVE COMPARATOR
Drug: Fentanyl

Interventions

ParacetamolDRUG

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

paracetamol
FentanylDRUG

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

fentanyl

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • ongoing chest pain \>30 minutes and \<12 hours duration and
  • ST-segment elevation \>0.1 milliVolt in at least 2 contiguous leads
  • 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

You may not qualify if:

  • i. presenting with cardiogenic shock; defined as:
  • systolic blood pressure \<90 mmHg and
  • heart rate \>100/min and
  • peripheral oxygen saturation \<90% (without oxygen administration)
  • 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:
  • hypersensitivity to aspirin or ticagrelor
  • current use of (new) oral anticoagulation
  • history of bleeding diathesis or known coagulopathy
  • active bleeding
  • refusal of blood transfusions
  • history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala clinics

Zwolle, Netherlands

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

AcetaminophenFentanyl

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial, with randomization to either paracetamol intravenously or fentanyl.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master of Science

Study Record Dates

First Submitted

October 30, 2017

First Posted

January 17, 2018

Study Start

February 16, 2018

Primary Completion

October 22, 2019

Study Completion

November 22, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

NL(1)