Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tenecteplase; Tissue Plasminogen Activator

Criteria

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