STEMIPhase 4ON-TIME 3NCT03400267
The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor
A Phase 4 study testing Paracetamol and Fentanyl in people with STEMI and STEMI - ST Elevation Myocardial Infarction, run by A.H. Tavenier at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI, STEMI - ST Elevation Myocardial Infarction
- What is being tested?
- Paracetamol and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Feb 2018to 22 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- referred by ambulance paramedics to Isala (Zwolle) or Zuyderland Hospital (Heerlen)
- 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
- ongoing chest pain with a pain score (NRS) ≥4
- 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
Who cannot join
- presenting with cardiogenic shock; defined as:
- systolic blood pressure <90 mmHg and
- heart rate >100/min and
- peripheral oxygen saturation <90% (without oxygen administration)
- patients with a nasogastric tube in situ or requiring a nasogastric tube
- patients who already received fentanyl or paracetamol <2 hours prior to randomization
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- patients on current treatment with P2Y12 inhibitors (ticagrelor, clopidogrel or prasugrel)
- allergy to morphine or paracetamol
- 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
- known severe liver dysfunction
- received any organ transplant or is on a waiting list for any organ transplant
- patients undergoing dialysis
- pregnant or lactating female
- patients currently participating in another investigational drug or device study
Trial locations and contacts
1 site in 1 country.
About this 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 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.
- Conditions
- STEMI, STEMI - ST Elevation Myocardial Infarction
- Being tested
- Paracetamol, Fentanyl
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
FentanylDrug
Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paracetamol |
| fentanyl | Active comparator | Not described Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
platelet reactivity
Platelet reactivity units (PRU) directly post-PCI or 1 hour post-angiography
Measured: directly post-PCI or 1 hour post-angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start16 Feb 2018
- Primary completion22 Oct 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial, with randomization to either paracetamol intravenously or fentanyl.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.H. Tavenier
- Sponsor type
- University, hospital or other
- Collaborators
- Isala
- Responsible party
- Sponsor-investigator, A.H. Tavenier, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400267
- Sponsor's protocol ID
- ON-TIME 3
- Acronym
- ON-TIME 3
- Status last verified
- Feb 2020
- First submitted
- 30 Oct 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor
- ClinicalTrials.gov ID
- NCT03400267
- Acronym / sponsor ID
- ON-TIME 3 / ON-TIME 3
- Conditions
- STEMI, STEMI - ST Elevation Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- A.H. TavenierUniversity, hospital or other
- Collaborators
- Isala
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial, with randomization to either paracetamol intravenously or fentanyl.
| Arm | Type | Receives |
|---|---|---|
| paracetamol | Active comparator | Drug: ParacetamolPatients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv. |
| fentanyl | Active comparator | Drug: Fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥18 years
- referred by ambulance paramedics to Isala (Zwolle) or Zuyderland Hospital (Heerlen)
- 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
Key exclusion criteria (20 listed)
- presenting with cardiogenic shock; defined as:
- systolic blood pressure <90 mmHg and
- heart rate >100/min and
- peripheral oxygen saturation <90% (without oxygen administration)
- patients with a nasogastric tube in situ or requiring a nasogastric tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolPatients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv. | Drug | paracetamol |
| FentanylPatients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv. | Drug | fentanyl |
Primary outcome
platelet reactivity
Time frame: directly post-PCI or 1 hour post-angiography
Platelet reactivity units (PRU) directly post-PCI or 1 hour post-angiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol and Fentanyl in people with STEMI and STEMI - ST Elevation Myocardial Infarction, run by A.H. Tavenier at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet reactivity (time frame: directly post-PCI or 1 hour post-angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.