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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)

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ClinicalTrials.gov Identifier: NCT01347580
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : February 11, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Segment Elevation Myocardial Infarction (STEMI) Drug: Ticagrelor Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1875 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : September 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Ticagrelor

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Ticagrelor
Oral Ticagrelor loading dose (180 mg) followed by matching placebo
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.
 Drug: Placebo
Placebo followed by oral Ticagrelor loading dose (180 mg)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347580


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Dr Judith Hsia, MD AstraZeneca
Principal Investigator: Pr Gilles Montalescot Pitie Salpetriere Hospital
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01347580    
Other Study ID Numbers: D5130L00006
First Posted: May 4, 2011    Key Record Dates
Results First Posted: February 11, 2015
Last Update Posted: July 22, 2015
Last Verified: July 2015
Keywords provided by AstraZeneca:
Heart attack
heart disease
cardiovascular disease
stroke
 reperfusion
pre hospital settings
ticagrelor
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs