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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191670
• Other study ID #: 1123.22
• Status: Completed
• Phase: N/A
• First received: July 14, 2014
• Last updated: July 14, 2014
• Start date: April 2005

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• METALYSE®
weight-adjusted dosage as single bolus over 5 to 10 seconds

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious adverse events (SAE)		up to 30 days	No
Secondary	In-hospital rate of death		up to 30 days	No
Secondary	In-hospital rate of stroke		up to 30 days	No
Secondary	In-hospital rate of intracranial hemorrhage		up to 30 days	No
Secondary	In-hospital rate of major bleeding		up to 30 days	No
Secondary	In-hospital rate of non-fatal cardiac events		up to 30 days	No
Secondary	Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke		up to 30 days	No

External Links

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