A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI) "ATLANTIC"

Completed

Phase 4 Results

Trial Description

The aim of this study is to determine whether initiation of ticagrelor as early as in the ambulance setting leads to a rapid reperfusion of the infarct-related artery therefore facilitating the Percutaneous Coronary Intervention (PCI) and optimizing the outcome for the patient.
The study will assess the efficacy and safety of pre-hospital compared to in-hospital administration of ticagrelor in co-administration with aspirin, on restoring the blood flow in the occluded heart artery and improving the myocardial perfusion in patients suffering from myocardial infarction and planned to have a PCI. Patients can be randomised in either one of the 2 arms:
re-hospital ticagrelor arm: Patients will receive a loading dose of 180 mg ticagrelor for the pre-hospital administration and placebo for in-hospital administration.
or In-hospital ticagrelor arm: Patients will receive a placebo for pre-hospital administration and 180 mg ticagrelor loading dose for in-hospital administration.
Patients are initially managed by ambulance physician/personnel in pre hospital settings. They are then transferred into a Catheterization room to undergo a PCI.
After the administration of the loading dose of ticagrelor (double blind), patients will continue on ticagrelor 90 mg bid and be followed in study for 30 days post randomisation.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo followed by oral Ticagrelor loading dose (180 mg)
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
  • Ticagrelor Drug
    Other Names: Brilinta/Brilique
    Intervention Desc: Oral Ticagrelor loading dose (180 mg) followed by matching placebo
    ARM 1: Kind: Experimental
    Label: Ticagrelor
    Description: Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Thrombolysis In Myocardial Infarction (TIMI) flow grade 3 of MI culprit vessel at initial angiography (co-primary endpoint) At initial angiography, pre PCI No
Primary ST-segment resolution up to pre PCI ≥70% (co-primary endpoint) Between baseline and PCI No
Secondary Percentage of patients with composite of death during the 30 days of treatment No
Secondary Percentage of patients presenting an acute stent thrombosis episode during 30 days of treatment No
Secondary The total number of patients with major life-threatening bleeding events within the first 48 hours and during 30 days of treatment No
Secondary Total number of patients with other major bleeding events within the first 48 hours and during 30 days of treatment No
Secondary Total number of patients with minor or major bleeding events within the first 48 hours and during 30 days of treatment No
Secondary Percentage of patients with MI during the 30 days of treatment No
Secondary Percentage of patients with urgent revascularization during the 30 days of treatment No
Primary ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint) Between baseline and PCI No
Secondary 1st Composite Clinical Endpoint during the 30 days of treatment No
Secondary 2nd Composite Clinical Endpoint within 30 days of study No
Secondary Definite Stent Thrombosis during 30 days of treatment No
Secondary TIMI Flow Grade 3 Post -PCI at coroangiography post-PCI No
Secondary ST Segment Elevation Resolution Post-PCI >= 70% Between baseline and ECG 60 mn post-PCI No
Secondary Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI during PCI No
Secondary Major Bleeds Within 48 Hours within 48 hours of first dose No
Secondary Minor and Major Bleedings Within 48 Hours within 48 hours of first dose No
Secondary Major Bleeds After 48 Hours after 48hours post-first dose No
Secondary Minor and Major Bleeds After 48 Hours after 48 hours post first dose No

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