Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AO GENERIUM | INDUSTRY |
Not provided
Not provided
Not provided
This study aims at evaluating of the effectiveness of in-hospital thrombolysis for ST-segment elevation myocardial infarction in PCI centers under conditions of predicted in-hospital delay (>60 min after admission in PCI-center) of PCI. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 2-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-hospital thrombolysis in PCI-center | Experimental | In-hospital thrombolysis with tenecteplase in case of predicted delayed pPCI (>60 min after admission in PCI-center). Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention. |
|
| Primary PCI in PCI-center | Active Comparator | Standard primary PCI in case of predicted delayed pPCI (>60 min after admission in PCI-center). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single, weight-adjusted i.v. bolus of tenecteplase | Drug | Single, weight-adjusted i.v. bolus of tenecteplase in case of >60 min in-hospital delay in PCI center |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of observed patients with cardiovascular death, nonfatal stroke, and nonfatal AMI within 12 months for FAS. | Participants achieved a response if they have cardiovascular death or nonfatal stroke, or nonfatal AMI at 12 months. | From enrollment to the end of follow-up (12 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with all-cause mortality | during hospitalization (assessed up to 10 days) | |
| Number of patients with cardiovascular mortality | during hospitalization (assessed up to 10 days) | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rimma Gulyan | Contact | +79152284043 | rimmagulyan5@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Dmitry Pevzner, Doctor of Medical Sciences | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | Study Director |
| Rimma Gulyan | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | Moscow | Select A State | 121552 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| catheterisation | Procedure | Standard primary PCI |
|
|
| Number of patients with non-fatal MI |
| during hospitalization (assessed up to 10 days) |
| Number of patients with hemorrhagic stroke | during hospitalization (assessed up to 10 days) |
| Number of patients with major bleeding according to the BARC scale (type 3-5) | during hospitalization (assessed up to 10 days) |
| Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications ) | during hospitalization (assessed up to 10 days) |
| Number of patients with all-cause mortality | 12 months |
| Number of patients with cardiovascular mortality | 12 months |
| Number of patients with non-fatal MI | 12 months |
| Number of patients with hemorrhagic stroke | 12 months |
| Number of patients with major bleeding according to the BARC scale (type 3-5) | 12 months |
| Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications) | 12 months |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D012847 | Single Person |
| D002404 | Catheterization |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided