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The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor (ON-TIME 3)

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ClinicalTrials.gov Identifier: NCT03400267
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Isala
Information provided by (Responsible Party):
A.H. Tavenier, Isala

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.

Condition or disease Intervention/treatment Phase
STEMI STEMI - ST Elevation Myocardial Infarction Drug: Paracetamol Drug: Fentanyl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial, with randomization to either paracetamol intravenously or fentanyl.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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

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




Primary Outcome Measures :
  1. platelet reactivity [ Time Frame: directly post-PCI or 1 hour post-angiography ]
    Platelet reactivity units (PRU) directly post-PCI or 1 hour post-angiography



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  1. ongoing chest pain >30 minutes and <12 hours duration and
  2. 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

Exclusion Criteria:

i. presenting with cardiogenic shock; defined as:

  1. systolic blood pressure <90 mmHg and
  2. heart rate >100/min and
  3. 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:

  1. hypersensitivity to aspirin or ticagrelor
  2. current use of (new) oral anticoagulation
  3. history of bleeding diathesis or known coagulopathy
  4. active bleeding
  5. refusal of blood transfusions
  6. history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
  7. known severe liver dysfunction

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400267


Contacts
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Contact: AH Tavenier, MD +31384244299 a.h.tavenier@isala.nl

Locations
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Netherlands
Isala clinics Recruiting
Zwolle, Netherlands
Contact: R Hermanides, MD/PHD         
Sponsors and Collaborators
A.H. Tavenier
Isala

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Responsible Party: A.H. Tavenier, Master of Science, Isala
ClinicalTrials.gov Identifier: NCT03400267     History of Changes
Other Study ID Numbers: ON-TIME 3
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Acetaminophen
Fentanyl
Ticagrelor
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents