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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01347580
First received: April 19, 2011
Last updated: July 20, 2015
Last verified: July 2015
April 19, 2011
July 20, 2015
September 2011
November 2013   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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 ]
  • ST-segment resolution pre PCI ≥70% (co-primary endpoint) [ Time Frame: Between baseline and PCI ]
Complete list of historical versions of study NCT01347580 on ClinicalTrials.gov Archive Site
  • 1st Composite Clinical Endpoint [ Time Frame: during the 30 days of treatment ]
    death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
  • 2nd Composite Clinical Endpoint [ Time Frame: within 30 days of study ]
    Death/MI/urgent revascularization. Adjudicated events except death
  • 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
  • TIMI Flow Grade 3 Post -PCI [ Time Frame: at coroangiography post-PCI ]
    TIMI) flow grade 3 is complete perfusion post-PCI.
  • 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
  • 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.
  • 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
  • Minor and Major Bleedings Within 48 Hours [ Time Frame: within 48 hours of first dose ]
    non CABG related bleeds (PLATO definition)
  • 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
  • Minor and Major Bleeds After 48 Hours [ Time Frame: after 48 hours post first dose ]
    non CABG related bleeds (PLATO definition)
  • Percentage of patients with composite of death [ Time Frame: during the 30 days of treatment ]
  • Percentage of patients presenting an acute stent thrombosis episode [ Time Frame: during 30 days of treatment ]
  • The total number of patients with major life-threatening bleeding events [ Time Frame: within the first 48 hours and during 30 days of treatment ]
  • Total number of patients with other major bleeding events [ Time Frame: within the first 48 hours and during 30 days of treatment ]
  • Total number of patients with minor or major bleeding events [ Time Frame: within the first 48 hours and during 30 days of treatment ]
  • Percentage of patients with MI [ Time Frame: during the 30 days of treatment ]
  • Percentage of patients with urgent revascularization [ Time Frame: during the 30 days of treatment ]
Not Provided
Not Provided
 
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)
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Myocardial Infarction
  • Segment Elevation Myocardial Infarction (STEMI)
  • Drug: Ticagrelor
    Oral Ticagrelor loading dose (180 mg) followed by matching placebo
  • Drug: Placebo
    Placebo followed by oral Ticagrelor loading dose (180 mg)
  • Experimental: Ticagrelor
    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.
    Intervention: Drug: Ticagrelor
  • Experimental: Placebo
    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.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1875
November 2013
November 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Algeria,   Australia,   Austria,   Canada,   Denmark,   France,   Germany,   Hungary,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
Israel
 
NCT01347580
D5130L00006
No
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Dr Judith Hsia, MD AstraZeneca
Principal Investigator: Pr Gilles Montalescot Pitie Salpetriere Hospital
AstraZeneca
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP