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The primary objective of ASSENT 3 Plus (the same as for ASSENT 3) was to evaluate the safety and efficacy of full dose tenecteplase combined with unfractionated heparin (UFH, group A) and full dose tenecteplase combined with enoxaparin (ENOX, group B). An additional objective in ASSENT 3 Plus was to describe the different time intervals in the prehospital phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tenecteplase + unfractioned heparin | Active Comparator |
| |
| tenecteplase + enoxaparin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full dose tenecteplase | Drug |
| ||
| Unfractioned heparin |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia or in-hospital intracranial hemorrhage (ICH) or in-hospital major bleedings (other than ICH) | Up to 30 days after discharge from hospital | |
| Composite endpoints: 30-day mortality or in-hospital reinfarction or in-hospital refractory ischemia | Up to 30 days after discharge from hospital |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| Enoxaparin | Drug |
|
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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