Myocardial InfarctionNCT02191670
Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation
An observational study of Myocardial Infarction, run by Boehringer Ingelheim.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- METALYSE®
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jan 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: A Post-registration, Open Label Therapeutic Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation.
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
- Being tested
- METALYSE®
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
METALYSE®Drug
weight-adjusted dosage as single bolus over 5 to 10 seconds
| Study group | Role | What they receive |
|---|---|---|
| METALYSE® | Not described Receives: Drug: METALYSE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse events (SAE)
Measured: up to 30 days
Secondary outcomes (6)
In-hospital rate of death
Measured: up to 30 days
In-hospital rate of stroke
Measured: up to 30 days
In-hospital rate of intracranial hemorrhage
Measured: up to 30 days
In-hospital rate of major bleeding
Measured: up to 30 days
In-hospital rate of non-fatal cardiac events
Measured: up to 30 days
Clinical benefit of routine use of Metalyse®, defined as the absence of 30- day mortality and in-hospital disabling stroke
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startApr 2005
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191670
- Sponsor's protocol ID
- 1123.22
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-registration, Open Label Therapeutic Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation.
- ClinicalTrials.gov ID
- NCT02191670
- Acronym / sponsor ID
- 1123.22
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jan 2006 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| METALYSE® | – | Drug: METALYSE® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| METALYSE®weight-adjusted dosage as single bolus over 5 to 10 seconds | Drug | METALYSE® |
Primary outcome
Number of serious adverse events (SAE)
Time frame: up to 30 days
6 secondary outcomes
In-hospital rate of death
Time frame: up to 30 days
In-hospital rate of stroke
Time frame: up to 30 days
In-hospital rate of intracranial hemorrhage
Time frame: up to 30 days
In-hospital rate of major bleeding
Time frame: up to 30 days
In-hospital rate of non-fatal cardiac events
Time frame: up to 30 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of serious adverse events (SAE) (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.