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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02191670
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Myocardial Infarction Drug: METALYSE®

Study Design

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-registration, Open Label Therapeutic Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation.
Study Start Date : April 2005
Primary Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Number of serious adverse events (SAE) [ Time Frame: up to 30 days ]

Secondary Outcome Measures :
  1. In-hospital rate of death [ Time Frame: up to 30 days ]
  2. In-hospital rate of stroke [ Time Frame: up to 30 days ]
  3. In-hospital rate of intracranial hemorrhage [ Time Frame: up to 30 days ]
  4. In-hospital rate of major bleeding [ Time Frame: up to 30 days ]
  5. In-hospital rate of non-fatal cardiac events [ Time Frame: up to 30 days ]
  6. Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke [ Time Frame: up to 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
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
More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02191670     History of Changes
Other Study ID Numbers: 1123.22
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tenecteplase
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action