Phase 4 Completed NCT03400267

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

A.H. Tavenier · Interventional, Randomized

12 views
Rate this page
Completed November 2019. Read the results summary below →
Study context Single-site study

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT03400267).

Results summary

None

Outcome data

EndpointTypeResultSignificance
platelet reactivity Primary None None

Full results record on ClinicalTrials.gov.

Study design

Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Masking
Open label
Intervention model
Parallel assignment
Primary purpose
Treatment
Enrollment (final)
200 participants
Started
February 2018
Actually completed
November 2019

Recruitment criteria

Age range: ≥ 18 · Sex: All · Healthy volunteers: Requires diagnosis

Locationsi

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

Isala clinics — Zwolle (Netherlands)

Sources

REG
ClinicalTrials.gov — NCT03400267
Trial registry · primary record
How would you rate this page?
Your feedback helps us improve the quality of our content.
What did you like about this page?
What did you not like about this page?
Is there anything else you'd like to see covered?
Report an error
All reports are reviewed before any changes are made.
What type of error are you reporting?
Which section does this relate to?
Please describe the error
Be as specific as possible — include the correct information if you know it.
Highlight mode — select the text containing the error
Click and drag over the relevant text, then click Confirm.
Thank you
Your response helps us improve the quality of this page.