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

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: METALYSE®

• Registration Number: NCT02191670
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2006-01
• Status Verified: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-14
• Last Update Submitted: 2014-07-14
• Study First Posted: 2014-07-16
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
METALYSE®	METALYSE®	-

Primary Outcome Measures

Name	Time	Method
Number of serious adverse events (SAE)	up to 30 days

Secondary Outcome Measures

Name	Time	Method
In-hospital rate of non-fatal cardiac events	up to 30 days
In-hospital rate of major bleeding	up to 30 days
In-hospital rate of death	up to 30 days
In-hospital rate of stroke	up to 30 days
In-hospital rate of intracranial hemorrhage	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