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 is currently recruiting participants.
Verified December 2012 by AstraZeneca
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01347580
First received: April 19, 2011
Last updated: December 20, 2012
Last verified: December 2012
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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:
MedlinePlus related topics:
Heart Attack
Drug Information available for:
Ticagrelor
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 1770 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347580
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Contacts
| Contact: AstraZeneca Clinical Study Information | + 331 41 29 41 00 |
Show 103 Study LocationsSponsors 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 20, 2012 |
| 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 Israel: Ministry of Health 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 |
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 May 16, 2013