A 30 day study to evaluate efficacy and safety of pre-hospital vs. in-hospital initiation of ticagrelor therapy in STEMI patients planned for PCI

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 - ATLANTIC

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000214-19-GB

Enrollment

1770

Registered

2011-03-30

Start date

2011-07-13

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myocardial infarction, STEMI patients planned for Percutaneous Coronary Intervention MedDRA version: 14.1 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Brilique Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ticagrelor CAS Number: 274693-27-5 Current Sponsor code: AZD6140 Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult men and women aged 18 years or older. Women must not be of child-bearing potential (1 year post-menopausal or surgically sterile). 2. Symptoms of acute MI of more than 30 min but less than 6 hours 3. New persistent ST-segment elevation = 1 mm in two or more contiguous ECG leads. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 885 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 885

Exclusion criteria

Exclusion criteria: 1. Expected time to 1st PCI balloon inflation in the hospital, from the qualifying ECG is more than 120 minutes 2. Contraindication to ticagrelor (refer to SmPC) 3. 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] 4. 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. 5. Patients who has received a loading dose for the index event or who are on chronic treatment of prasugrel, clopidogrel or ticagrelor (commercial pack)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of pre-hospital vs. in-hospital initiation of ticagrelor therapy by comparing the percentage of patients reaching the co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a =70% ST-segment elevation resolution pre-PCI;Secondary Objective: •Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis during 30 days of treatment •Composite of death, MI, urgent revascularization during 30 days of treatment •Acute stent thrombosis during 30 days of treatment •Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI •Complete (> 70%) ST-segment elevation resolution at 60 min post-PCI •Corrected TIMI frame count, TIMI myocardial perfusion grade at angiography, pre and post PCI. •Time–relationship (from symptom onset to 1st dose intake ) on each co-primary •Time–relationship (from 1st dose intake to ECG/ angiography) on each co-primary •TIMI flow grade 3 at end of procedure Assess the occurrence of major life-threatening bleeding events, other major bleeding events and minor or major bleeding events ;Primary end point(s): The percentage of patients reaching TIMI flow grade 3 of MI culprit vessel at initial angiography or a =70% ST-segment resolution pre PCI (co-primary endpoint);Timepoint(s) of evaluation of this end point: between baseline and PCI	—

Measure

Time frame

Main Objective: To assess the efficacy of pre-hospital vs. in-hospital initiation of ticagrelor therapy by comparing the percentage of patients reaching the co-primary endpoint of TIMI flow grade 3 of MI culprit vessel at initial angiography or a =70% ST-segment elevation resolution pre-PCI;Secondary Objective: •Composite of death, MI, stroke, urgent revascularization and acute stent thrombosis during 30 days of treatment •Composite of death, MI, urgent revascularization during 30 days of treatment •Acute stent thrombosis during 30 days of treatment •Thrombotic bail-out with GPIIb/IIIa inhibitors at initial PCI •Complete (> 70%) ST-segment elevation resolution at 60 min post-PCI •Corrected TIMI frame count, TIMI myocardial perfusion grade at angiography, pre and post PCI. •Time–relationship (from symptom onset to 1st dose intake ) on each co-primary •Time–relationship (from 1st dose intake to ECG/ angiography) on each co-primary •TIMI flow grade 3 at end of procedure Assess the occurrence of major life-threatening bleeding events, other major bleeding events and minor or major bleeding events ;Primary end point(s): The percentage of patients reaching TIMI flow grade 3 of MI culprit vessel at initial angiography or a =70% ST-segment resolution pre PCI (co-primary endpoint);Timepoint(s) of evaluation of this end point: between baseline and PCI

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Secondary

Measure	Time frame
Secondary end point(s): 1. Percentage of patients in the following: composite of death, MI, stroke, urgent revascularization and acute stent thrombosis 2. Percentage of patients presenting an acute stent thrombosis episode 3. Bleeding events a) The total number of patients with major life-threatening bleeding events b) Total number of patients with other major bleeding events, c) Total number of patients with minor or major bleeding events ;Timepoint(s) of evaluation of this end point: 1. during the 30 days of treatment 2. during the 30 days of treatment 3. within the first 48 hours and during 30 days of treatment	—

Measure

Time frame

Secondary end point(s): 1. Percentage of patients in the following: composite of death, MI, stroke, urgent revascularization and acute stent thrombosis 2. Percentage of patients presenting an acute stent thrombosis episode 3. Bleeding events a) The total number of patients with major life-threatening bleeding events b) Total number of patients with other major bleeding events, c) Total number of patients with minor or major bleeding events ;Timepoint(s) of evaluation of this end point: 1. during the 30 days of treatment 2. during the 30 days of treatment 3. within the first 48 hours and during 30 days of treatment

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Countries

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

Contacts

Public ContactInformation Center

AstraZeneca

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 24, 2026