The effect of Opioids on P2Y12 Receptor Inhibition in patients with ST-Elevation Myocardial Infarction who are pre-treated with crushed Ticagrelor

Phase 1

• Conditions: Acute Coronary syndrome; MedDRA version: 20.0Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000011652; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002671-26-NL
• Lead Sponsor: Isala

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-17
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1.age =18 years
2.referred by ambulance paramedics to Isala (Zwolle) or Zuyderland
Hospital (Heerlen)
3.diagnosed in the ambulance with STEMI defined as:
- ongoing chest pain >30 minutes and <12 hours duration and
- ST-segment elevation >0.1 mV in at least 2 contiguous leads
4.ongoing chest pain with a pain score (NRS) =4
5.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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95

Exclusion Criteria

A potential subject will be excluded from participation in this study when any of the following criteria is met:
1.presenting with cardiogenic shock; defined as:
-systolic blood pressure <90 mmHg and
-heart rate >100/min and
-peripheral oxygen saturation <90% (without oxygen
administration)
2.patients with a nasogastric tube in situ or requiring a nasogastric
tube
3.patients who already received fentanyl or paracetamol <2 hours
prior to randomization
4.patients on current treatment with P2Y12 inhibitors
(ticagrelor, clopidogrel or prasugrel)
5.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
-refusal of blood transfusions
-history of intracerebral mass, aneurysm, arteriovenous
malformation, or hemorrhagic stroke
-known severe liver dysfunction
6.received any organ transplant or is on a waiting list for any organ
transplant
7.patients undergoing dialysis
8.pregnant or lactating female
9.patients currently participating in another investigational drug or
device study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified