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NCT Number: NCT01347580

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)

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.

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Key information

Conditions

Myocardial Infarction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Segment Elevation Myocardial Infarction (STEMI) Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Algiers, Algeria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women must not be of child-bearing potential (1 year post-menopausal or surgically sterile).
  • Symptoms of acute MI of more than 30 min but less than 6 hours
  • New persistent ST-segment elevation ≥ 1 mm in two or more contiguous electrocardiogram (ECG) leads.

Exclusion criteria

  • Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is more than 120 minutes
  • Contraindication to ticagrelor (refer to SmPC)
  • Concomitant medication that may increase the risk of bleeding [e.g non steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulant and / or fibrinolytics, planned or administered 24 hours before randomization]
  • Any of the following conditions in the absence of a functioning implanted pacemaker: known SSS, second or third degree AVB, or documented syncope of suspected bradycardic origin.

Treatment and study plan

Ticagrelor

Drug

Oral Ticagrelor loading dose (180 mg) followed by matching placebo

Placebo

Drug

Placebo followed by oral Ticagrelor loading dose (180 mg)

Primary outcomes

  1. Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)

    Time frame: At initial angiography, pre PCI

    (TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.

  2. ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)

    Time frame: Between baseline and PCI

    ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.

Secondary outcomes

  1. 1st Composite Clinical Endpoint

    Time frame: during the 30 days of treatment

    death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death

  2. 2nd Composite Clinical Endpoint

    Time frame: within 30 days of study

    Death/MI/urgent revascularization. Adjudicated events except death

  3. Definite Stent Thrombosis

    Time frame: during 30 days of treatment

    Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint

  4. TIMI Flow Grade 3 Post -PCI

    Time frame: at coroangiography post-PCI

    TIMI) flow grade 3 is complete perfusion post-PCI.

  5. ST Segment Elevation Resolution Post-PCI >= 70%

    Time frame: Between baseline and ECG 60 mn post-PCI

    ST segment elevation resolution post PCI >=70% is defined as complete resolution

  6. Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI

    Time frame: during PCI

    Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.

  7. Major Bleeds Within 48 Hours

    Time frame: within 48 hours of first dose

    non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds

  8. Minor and Major Bleedings Within 48 Hours

    Time frame: within 48 hours of first dose

    non CABG related bleeds (PLATO definition)

  9. Major Bleeds After 48 Hours

    Time frame: after 48hours post-first dose

    non CABG related bleeds (PLATO definition) include life threatening and other major bleedings

  10. Minor and Major Bleeds After 48 Hours

    Time frame: after 48 hours post first dose

    non CABG related bleeds (PLATO definition)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 30 Day International, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase IV Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for PCI.

Acronym: ATLANTIC

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 4, 2011
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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