Status:
COMPLETED
Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02191670
Start Date
April 1 2005
Last Update
July 16 2014
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