Overview

Platelet Inhibition After Pre-hospital Ticagrelor Using Fentanyl Compared to Morphine in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Status:
Completed
Trial end date:
2018-02-06
Target enrollment:
0
Participant gender:
All
Summary
Prospective, randomized, open-label, single-center, investigator-initiated trial, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) within 12 hours of the symptom's onset. The study aims to compare platelet inhibition (pharmacodynamics and pharmacokinetics) of pre-hospital Ticagrelor in patients with STEMI according to two different analgesia protocols using Fentanyl or Morphine.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborator:
AstraZeneca
Treatments:
Aspirin
Calcium heparin
Fentanyl
Heparin
Morphine
Ticagrelor
Criteria
Inclusion Criteria:

- Age >18-year-old

- STEMI within 12 hours of symptoms' onset eligible for primary PCI with stent
implantation.

- Patient able to give written informed consent.

Exclusion Criteria:

- Contraindication, intolerance or hypersensitivity to Ticagrelor, or any excipients

- Contraindication, intolerance or hypersensitivity to Morphine, Fentanyl, or any
excipients

- Active bleeding or bleeding diathesis

- History of intracranial haemorrhage

- Chronic oral anticoagulation treatment

- Previous antiplatelet treatment

- Contraindications to antiplatelet therapy

- Severe renal insufficiency (creatinine clearance <30 mL/min)

- Severe hepatic dysfunction

- Severe chronic obstructive pulmonary disease

- Periprocedural glycoprotein IIb/IIIa inhibitors administration

- Relevant haematological disease

- Patient who is currently, plans, or has been enrolled in another clinical study
involving use of an investigational drug or device within the prior 30 days.

- If female, patient pregnant or breastfeeding.