Clinical trial NCT02191670: Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation
Official title: A Post-registration, Open Label Therapeutic Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

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


Eligibility 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

Primary outcomes:
measure: Number of serious adverse events (SAE)
timeFrame: up to 30 days
Secondary outcomes:
measure: In-hospital rate of death
timeFrame: up to 30 days
measure: In-hospital rate of stroke
timeFrame: up to 30 days
measure: In-hospital rate of intracranial hemorrhage
timeFrame: up to 30 days
measure: In-hospital rate of major bleeding
timeFrame: up to 30 days
measure: In-hospital rate of non-fatal cardiac events
timeFrame: up to 30 days
measure: Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke
timeFrame: up to 30 days
Other outcomes:
Locations:
Study officials:
References: