Myocardial Infarction
Conditions
Brief summary
Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation. Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction in usual routine treatment after market launch
Interventions
DRUGMETALYSE®
weight-adjusted dosage as single bolus over 5 to 10 seconds
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* onset of symptoms of AMI within 6 hours * on a twelve-lead electrocardiogram (ECG), ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or \> 0.2 mV in two or more contiguous precordial leads indicative of AMI, or left bundle-branch block * age ≥ 18
Exclusion criteria
* significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis * patients with current concomitant oral anticoagulant therapy with International Normalised Ratio (INR) \> 1.3 * any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) * severe uncontrolled arterial hypertension (hypertension defined as blood pressure 180/110 mm Hg (systolic BP \> 180 mm Hg and/or diastolic BP \> 100 mm Hg) on one single reliable measurement during current admission prior to study enrolment * major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI), recent trauma to the head or cranium * prolonged or traumatic cardiopulmonary resuscitation (\> 2 minutes) within the past 2 weeks * severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis * diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions * active peptic ulceration * arterial aneurysm and known arterial/venous malformation * neoplasm with increased bleeding risk * Acute pericarditis and/or subacute bacterial endocarditis * Acute pancreatitis * hypersensitivity to the active substance tenecteplase and to any of the excipients * use of Abciximab (ReoPro®) or other marketed GPIIb/IIIa antagonists within the preceding 12 hours * any minor head trauma and any other trauma occurring after onset of the current myocardial infarction * any known history of stroke or transient ischemic attack or dementia * pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test * any known active participation in another investigative drug study or device protocol in the past 30 days * previous enrollment in this study * inability to follow protocol and comply with follow-up requirements * any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of serious adverse events (SAE) | up to 30 days |
Secondary
| Measure | Time frame |
|---|---|
| In-hospital rate of stroke | up to 30 days |
| In-hospital rate of intracranial hemorrhage | up to 30 days |
| In-hospital rate of death | up to 30 days |
| In-hospital rate of non-fatal cardiac events | up to 30 days |
| Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke | up to 30 days |
| In-hospital rate of major bleeding | up to 30 days |
Outcome results
None listed