E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
myocardial infarction, STEMI patients planned for Percutaneous Coronary Intervention
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E.1.1.1 | Medical condition in easily understood language |
heart disease, cardiovascular disease
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
•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
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PRIVATE-ATLANTIC Substudy: P2Y12 Receptor Inhibition with VASP Testing using Elisa kit during the Administration of Ticagrelor in the Cath Lab or in the Ambulance for New ST elevation Myocardial Infarction to open the Coronary Artery. Edition 1 date 19 Dec 2011
The PRIVATE-ATLANTIC substudy has pharmacodynamic, pharmacokinetic and exploratory objectives. It seeks to evaluate the pharmacokinetic profiles of ticagrelor at several timepoints in the first 12 hours and the pharmacodynamics of pre-hospital oral P2Y12 blockade to confirm that a high level of platelet inhibition can be reached faster with ticagrelor during the transport phase of STEMI. |
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E.3 | Principal 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.
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | 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) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 90 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 20 |
E.8.9.2 | In all countries concerned by the trial days | 0 |