Status:
COMPLETED
The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor
Lead Sponsor:
A.H. Tavenier
Collaborating Sponsors:
Isala
Conditions:
STEMI
STEMI - ST Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03400267
Start Date
February 16 2018
End Date
November 22 2019
Last Update
February 12 2020
Active Locations (1)
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1
Isala clinics
Zwolle, Netherlands