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

A Post-registration, Open Label Therapeutic Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation.

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

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: METALYSE®

• Study Type: Observational
• Enrollment (Actual): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
METALYSE®	Drug: METALYSE®; weight-adjusted dosage as single bolus over 5 to 10 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of serious adverse events (SAE)	up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
In-hospital rate of major bleeding	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tenecteplase
• Other Study ID Numbers: 1123.22