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

NCT02191670 | Completed

• 1 other identifier: 1123.22
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Number of serious adverse events (SAE)

  up to 30 days

Secondary Outcomes (6)

• 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

Study Arms (1)

METALYSE®

Drug: METALYSE®

Interventions

METALYSE® DRUG

weight-adjusted dosage as single bolus over 5 to 10 seconds

METALYSE®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: April 1, 2005
• Primary Completion: January 1, 2006
• Last Updated: July 16, 2014

Record last verified: 2014-07