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)

Myocardial Infarction Clinical Trial

— ATLANTIC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347580
• Other study ID #: D5130L00006
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2011
• Last updated: July 20, 2015
• Start date: September 2011
• Est. completion date: November 2013

Study information

• Verified date: July 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyAustria: Federal Office for Safety in Health CareCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)Spain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyHungary: National Institute of PharmacyAustralia: Queensland Health AuthoritiesAlgeria: Ministère de la Santé, de la Population et de la Réforme Hospitalière
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1875
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Segment Elevation Myocardial Infarction (STEMI)

Intervention

Drug:
• Ticagrelor
Oral Ticagrelor loading dose (180 mg) followed by matching placebo
• Placebo
Placebo followed by oral Ticagrelor loading dose (180 mg)

Locations

Country	Name	City	State
Algeria	Research Site	Algiers
Algeria	Research Site	Blida
Australia	Research Site	Herston
Australia	Research Site	Southport
Australia	Research Site	Woolloongabba
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Wien
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Regina	Saskatchewan
Canada	Research Site	Scarborough	Ontario
Denmark	Research Site	Aalborg
Denmark	Research Site	Århus
Denmark	Research Site	Odense C
France	Research Site	Aubervilliers
France	Research Site	Besançon
France	Research Site	Boulogne Billancourt
France	Research Site	Bourges
France	Research Site	Bron
France	Research Site	Chateauroux
France	Research Site	Corbeil Essonnes Cedex
France	Research Site	Creteil
France	Research Site	Dijon
France	Research Site	LAGNY SUR MARNE cedex
France	Research Site	Le Chesnay
France	Research Site	Le Coudray
France	Research Site	Lyon
France	Research Site	Lyon Cedex 04
France	Research Site	Marseille
France	Research Site	MARSEILLE cedex 15
France	Research Site	Massy
France	Research Site	Melun
France	Research Site	Montauban
France	Research Site	Montfermeil
France	Research Site	MONTREUIL Cedex
France	Research Site	Neuilly Sur Seine
France	Research Site	Nimes
France	Research Site	Paris
France	Research Site	Paris Cedex 13
France	Research Site	PARIS Cedex 15
France	Research Site	PESSAC Cedex
France	Research Site	Quincy sous Sénart
France	Research Site	Rouen Cedex
France	Research Site	Strasbourg
France	Research Site	TOURS cedex
France	Research Site	TOURS Cedex 9
France	Research Site	VANNES cedex
Germany	Research Site	Bad Friedrichshall
Germany	Research Site	Bad Nauheim
Germany	Research Site	Darmstadt
Germany	Research Site	Esslingen
Germany	Research Site	Freiburg
Germany	Research Site	Gießen
Germany	Research Site	Hannover
Germany	Research Site	Lüdenscheid
Germany	Research Site	Ludwigshafen
Germany	Research Site	Mainz
Germany	Research Site	Merseburg
Germany	Research Site	Wuppertal
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Pécs
Hungary	Research Site	Szeged
Italy	Research Site	Arezzo
Italy	Research Site	Ascoli Piceno
Italy	Research Site	Cona
Italy	Research Site	Forlì
Italy	Research Site	Genova
Italy	Research Site	Grosseto
Italy	Research Site	Massa
Italy	Research Site	Seriate
Italy	Research Site	Siena
Netherlands	Research Site	Alkmaar
Netherlands	Research Site	Arnhem
Netherlands	Research Site	Den Bosch
Netherlands	Research Site	Terneuzen
Spain	Research Site	A Coruña
Spain	Research Site	Alicante
Spain	Research Site	Badalona
Spain	Research Site	Barcelona
Spain	Research Site	Hospitalet de Llobregat(Barcel
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Santiago(A Coruña)
Spain	Research Site	Sevilla
Spain	Research Site	Vigo(Pontevedra)
Sweden	Research Site	Gävle
Sweden	Research Site	Linköping
Sweden	Research Site	Örebro
Sweden	Research Site	Uppsala
United Kingdom	Research Site	Ashford
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Eastbourne
United Kingdom	Research Site	Hastings
United Kingdom	Research Site	Middlesborough
United Kingdom	Research Site	Newcastle-Upon-Tyne
United Kingdom	Research Site	Norwich
United Kingdom	Research Site	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Algeria,  Australia,  Austria,  Canada,  Denmark,  France,  Germany,  Hungary,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Montalescot G, van 't Hof AW, Lapostolle F, Silvain J, Lassen JF, Bolognese L, Cantor WJ, Cequier A, Chettibi M, Goodman SG, Hammett CJ, Huber K, Janzon M, Merkely B, Storey RF, Zeymer U, Stibbe O, Ecollan P, Heutz WM, Swahn E, Collet JP, Willems FF, Bara — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)	(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.	At initial angiography, pre PCI	No
Primary	ST-segment Elevation Resolution Pre PCI =70% (Co-primary Endpoint)	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.	Between baseline and PCI	No
Secondary	1st Composite Clinical Endpoint	death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death	during the 30 days of treatment	No
Secondary	2nd Composite Clinical Endpoint	Death/MI/urgent revascularization. Adjudicated events except death	within 30 days of study	No
Secondary	Definite Stent Thrombosis	Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint	during 30 days of treatment	No
Secondary	TIMI Flow Grade 3 Post -PCI	TIMI) flow grade 3 is complete perfusion post-PCI.	at coroangiography post-PCI	No
Secondary	ST Segment Elevation Resolution Post-PCI >= 70%	ST segment elevation resolution post PCI >=70% is defined as complete resolution	Between baseline and ECG 60 mn post-PCI	No
Secondary	Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI	Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.	during PCI	No
Secondary	Major Bleeds Within 48 Hours	non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds	within 48 hours of first dose	No
Secondary	Minor and Major Bleedings Within 48 Hours	non CABG related bleeds (PLATO definition)	within 48 hours of first dose	No
Secondary	Major Bleeds After 48 Hours	non CABG related bleeds (PLATO definition) include life threatening and other major bleedings	after 48hours post-first dose	No
Secondary	Minor and Major Bleeds After 48 Hours	non CABG related bleeds (PLATO definition)	after 48 hours post first dose	No

External Links

•   D5130L00006_CSR_Synopsis
•   D5130L00006_Protocol