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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
Results First Received: November 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Myocardial Infarction
Segment Elevation Myocardial Infarction (STEMI)
Interventions: Drug: Ticagrelor
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were randomized in pre-hospital settings at 102 Emergency Medical Services between September 2011 and October 2013. 1875 patients were recruited in the study, 1862 consented patients were randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pre-hospital 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.
In-hospital Ticagrelor 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.

Participant Flow:   Overall Study
    Pre-hospital Ticagrelor   In-hospital Ticagrelor
STARTED   909 [1]   953 [1] 
Modified Intent to Treat Population   906 [1]   952 [1] 
Safety Population   908 [2]   950 [2] 
COMPLETED   844 [1]   897 [1] 
NOT COMPLETED   65   56 
Withdrawal by Subject                13                23 
Death                30                19 
Protocol Violation                10                7 
Lost to Follow-up                3                1 
Had other reason                9                6 
[1] based on randomized treatment
[2] based on actual treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pre-hospital 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.
In-hospital Ticagrelor 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.
Total Total of all reporting groups

Baseline Measures
   Pre-hospital Ticagrelor   In-hospital Ticagrelor   Total 
Overall Participants Analyzed 
[Units: Participants]
 909   953   1862 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Years   60.6  (12.38)   61.0  (12.49)   60.8  (12.43) 
Gender 
[Units: Participants]
     
Female   173   196   369 
Male   736   757   1493 
Diabetes mellitus 
[Units: Patients]
     
yes   115   138   253 
no/unknown   794   815   1609 
TIMI risk score [1] 
[Units: Patients]
     
0-2   552   573   1125 
3-6   337   365   702 
>6   20   15   35 
[1] Thrombolysis in Myocardial Infarction (TIMI) is a scoring system based on independant predictors of mortality such as age, diabetes mellitus, history of hypertension, history of angina, ST segment elevation. The death rate at 30 days for the following scores are: 0-2: 0.8%-2.2%, 3-6: 4.4% -16.1%, score>6: 23.4% to 35.9%.
Killip class [1] 
[Units: Patients]
     
 819   862   1681 
II, III, IV   51   43   94 
unknown   39   48   87 
[1] Killip class assesses the presence and severity of heart failure by physical examination. Class I :No rales, no 3rd heart sound. Class 2: Rales in <1⁄2 lung field or presence of a 3rd heart sound. Class 3: Rales in >1⁄2 lung field–pulmonary edema.Class 4 : Cardiogenic shock–determined clinically.
First medical contact 
[Units: Patients]
     
in ambulance   689   723   1412 
in emergency department   220   230   450 
PCI [1] 
[Units: Patients]
     
yes   800   830   1630 
no   109   123   232 
[1] Percutaneous coronary intervention (PCI) is a non-surgery intervention performed to open blocked coronary arteries and to restore arterial blood flow to the heart tissue.
type of PCI [1] 
[Units: Patients]
     
with stent   760   776   1536 
without stent   40   54   94 
[1] on patients with PCI
Time between the 2 loading doses 
[Units: Minutes]
Median (Inter-Quartile Range)
 32 
 (22 to 45) 
 30 
 (22 to 43) 
 31 
 (22 to 44) 


  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)   [ Time Frame: Between baseline and PCI ]

3.  Secondary:   1st Composite Clinical Endpoint   [ Time Frame: during the 30 days of treatment ]

4.  Secondary:   2nd Composite Clinical Endpoint   [ Time Frame: within 30 days of study ]

5.  Secondary:   Definite Stent Thrombosis   [ Time Frame: during 30 days of treatment ]

6.  Secondary:   TIMI Flow Grade 3 Post -PCI   [ Time Frame: at coroangiography post-PCI ]

7.  Secondary:   ST Segment Elevation Resolution Post-PCI >= 70%   [ Time Frame: Between baseline and ECG 60 mn post-PCI ]

8.  Secondary:   Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI   [ Time Frame: during PCI ]

9.  Secondary:   Major Bleeds Within 48 Hours   [ Time Frame: within 48 hours of first dose ]

10.  Secondary:   Minor and Major Bleedings Within 48 Hours   [ Time Frame: within 48 hours of first dose ]

11.  Secondary:   Major Bleeds After 48 Hours   [ Time Frame: after 48hours post-first dose ]

12.  Secondary:   Minor and Major Bleeds After 48 Hours   [ Time Frame: after 48 hours post first dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

This urgent setting study included 8.6% of patients with symptoms of MI in ambulance but having finally not a STEMI diagnosis in cathlab.

No prespecified hypothesis and procedure for adjustment was made on secondary endpoints.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Tomas Andersson MD
Organization: AstraZeneca
phone: 00 46 31 77 61966
e-mail: tomas.lg.andersson@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01347580     History of Changes
Other Study ID Numbers: D5130L00006
Study First Received: April 19, 2011
Results First Received: November 13, 2014
Last Updated: July 20, 2015
Health Authority: Denmark: Danish Medicines Agency
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Australia: Queensland Health Authorities
Algeria: Ministère de la Santé, de la Population et de la Réforme Hospitalière