Clinical Trials
NORDISTEMI
Trial Details:
Acronym: Norwegian Study on District Treatment of ST Elevation Myocardial Infarction
Purpose: To evaluate the treatment approach to patients presenting late with myocardial infarction. Either immediate PCI versus thrombolytic therapy with possible rescue PCI were compared.
Format: Multicenter, randomized control trial
Treatment Group: Immediate percutaneous coronary intervention (PCI)
Control Group: Thrombolysis with tenecteplase and standard therapy - PCI only if clinical deterioration (rescue PCI)
Number of Patients: 266
Inclusion Criteria:
- Age > 18 and < 75
- Symptoms of acute MI for at least 6 hours
- ECG findings of acute MI including 2 mm of ST elecation in 2 contiguous precordial leads (V1-V6) OR 1 mm ST elevation in 2 contiguous limb leads OR new left bundle branch block (LBBB)
- Expected time to PCI 90 minutes
- Thrombolytic therapy with tenecteplase
Exclusion Criteria:
- Contraindication for tenecteplase
- Cardiogenic shock
- Severe arrhythmia (VT or ventricular fibrillation)
- Pregnancy
- Renal failure
- Serious illness with life expectancy < 12 months
- Conditions that may limit compliance (mental illness, non-cooperative patient)
Follow-up: 12 months
Primary Endpoint: Composite endpoint of all-cause mortality, reinfarction, stroke or new ischemia at 1 year
Secondary Endpoints:
- Composite endpoint of all-cause mortality, stroke, reinfarction, new ischemia, transport related complications, bleeding and infarct size at 30 days
- Major bleeding
- Infarct size as assessed by SPECT and troponin T levels
Summary:
Patients with delayed presentation of MI (symptoms for at least 6 hours) treated with immediate percutaneous coronary intervention (PCI) versus thrombolysis with possible rescue PCI if clinically indicated. Primary endpoint of composite death, reinfarction, stroke or new ischemia at 30 days was reduced, but not at 12 months. Secondary endpoint of composite death, stroke and reinfarction was reduced at 12 months, but not 30 days. There was no difference in bleeding in both groups.