Phase 4
N=1,862
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 · Segment Elevation Myocardial Infarction (STEMI)
Bottom Line
View on ClinicalTrials.gov: NCT01347580 ↗Enrolled (actual)
1,862
Serious AEs
15.2%
Results posted
Feb 2015
Primary outcome: Primary: Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint) — 143; 145 patients — p=0.8214
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ticagrelor (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint) |
143; 145 | 0.8214 |
| PRIMARY ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint) |
102; 102 | 0.6322 |
| SECONDARY 1st Composite Clinical Endpoint |
41; 42 | 0.9056 |
| SECONDARY 2nd Composite Clinical Endpoint |
39; 34 | 0.4168 |
| SECONDARY Definite Stent Thrombosis |
2; 11 | 0.0307 sig |
| SECONDARY TIMI Flow Grade 3 Post -PCI |
625; 630 | 0.344 |
| SECONDARY ST Segment Elevation Resolution Post-PCI >= 70% |
410; 390 | 0.0547 |
| SECONDARY Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI |
78; 100 | 0.1660 |
| SECONDARY Major Bleeds Within 48 Hours |
16; 15 | — |
| SECONDARY Minor and Major Bleedings Within 48 Hours |
24; 24 | — |
| SECONDARY Major Bleeds After 48 Hours |
11; 11 | — |
| SECONDARY Minor and Major Bleeds After 48 Hours |
18; 16 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01347580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.