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

NCT02531165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-07-15

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

Fentanyl

Analgesia protocol using Fentanyl (initial dose: 50-100 mcg, additional doses of 25 mcg every 2-5 minutes to achieve adequate sedation, if required).

DRUG

Morphine

Analgesia protocol using Morphine (initial dose: 4-8 mg, additional doses of 2 mg every 5-15 minutes to achieve adequate sedation, if required).

DRUG

Ticagrelor

Pre-hospital Ticagrelor loading dose of 180 mg administered orally, followed by 90 mg bid

DRUG

Aspirin

500 mg loading dose orally (or intravenously), followed by 100 mg od

DRUG

Unfractioned Heparin

5'000 IU loading dose intravenously, additional doses to achieve an ACT \>250 sec during PCI are allowed.

PROCEDURE

Primary PCI

Primary PCI with stent implantation according to the guidelines of the European Society of Cardiology.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Juan F. Iglesias, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-02-06
Completion
2018-02-06

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02531165 on ClinicalTrials.gov