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: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Myocardial Infarction
Segment Elevation Myocardial Infarction (STEMI)
Drug: Ticagrelor
Drug: Placebo
Phase 4

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
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • ST-segment resolution up to pre PCI ≥70% (co-primary endpoint) [ Time Frame: Between baseline and PCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with composite of death [ Time Frame: during the 30 days of treatment ] [ Designated as safety issue: No ]
  • Percentage of patients presenting an acute stent thrombosis episode [ Time Frame: during 30 days of treatment ] [ Designated as safety issue: No ]
  • The total number of patients with major life-threatening bleeding events [ Time Frame: within the first 48 hours and during 30 days of treatment ] [ Designated as safety issue: No ]
  • Total number of patients with other major bleeding events [ Time Frame: within the first 48 hours and during 30 days of treatment ] [ Designated as safety issue: No ]
  • Total number of patients with minor or major bleeding events [ Time Frame: within the first 48 hours and during 30 days of treatment ] [ Designated as safety issue: No ]
  • Percentage of patients with MI [ Time Frame: during the 30 days of treatment ] [ Designated as safety issue: No ]
  • Percentage of patients with urgent revascularization [ Time Frame: during the 30 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 1874
Study Start Date: September 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347580

  Show 100 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dr Judith Hsia, MD AstraZeneca
Principal Investigator: Pr Gilles Montalescot Pitie Salpetriere Hospital
  More Information

No publications provided by AstraZeneca

Additional 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
Last Updated: December 17, 2013
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

Keywords provided by AstraZeneca:
Heart attack
heart disease
cardiovascular disease
stroke
reperfusion
pre hospital settings
ticagrelor
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014