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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02191670
First received: July 14, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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 Intervention
Myocardial Infarction
Drug: METALYSE®

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of serious adverse events (SAE) [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-hospital rate of death [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
  • In-hospital rate of stroke [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
  • In-hospital rate of intracranial hemorrhage [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
  • In-hospital rate of major bleeding [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
  • In-hospital rate of non-fatal cardiac events [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2005
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
METALYSE® Drug: METALYSE®
weight-adjusted dosage as single bolus over 5 to 10 seconds

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02191670     History of Changes
Other Study ID Numbers: 1123.22
Study First Received: July 14, 2014
Last Updated: July 14, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tenecteplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on September 18, 2014