Alteplase
| Evidence Level: L4 | Predicted Indications: 9 |
Table of Contents
- Alteplase
- Alteplase: From Thrombolytic Therapy (Original Indication Not Recorded) to Posterolateral Myocardial Infarction
Alteplase: From Thrombolytic Therapy (Original Indication Not Recorded) to Posterolateral Myocardial Infarction
One-Sentence Summary
Alteplase is a recombinant tissue plasminogen activator (tPA) that dissolves fibrin clots. The TxGNN model predicts it may be effective for Posterolateral Myocardial Infarction, but there are currently 0 registered clinical trials and only 3 indirect publications (1 case report, 1 case report about PCI with a different drug, 1 diagnostic ECG cohort) supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the source record (the approved-indication text is empty) |
| Predicted New Indication | Posterolateral myocardial infarction |
| TxGNN Prediction Score | 99.79% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 1 (BLA103172) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the source record. Alteplase is a tissue-type plasminogen activator, and it works by breaking down fibrin in blood clots. That is the pharmacology behind the prediction.
Posterolateral myocardial infarction is an anatomical subtype of acute myocardial infarction, which is caused by an occlusive coronary thrombus. Dissolving that thrombus to restore blood flow is the rationale for thrombolysis in acute MI.
This is a subtype restatement rather than true repurposing. The evidence pack contains no alteplase data specific to the posterolateral subtype, so the high model score reflects the disease’s closeness to acute MI in general, not new subtype-specific findings.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 8480981 | 1993 | Case report | Ann Cardiol Angeiol | Cerebral embolism with rapid resolution during late tPA fibrinolysis in a posterolateral MI patient. The authors stress the risk of systemic embolism when fibrinolysis is given with left intraventricular thrombi. |
| 9502627 | 1998 | Cohort (diagnostic ECG study) | J Am Coll Cardiol | Examined whether ST elevation in posterior leads (V7–V9) during inferior MI identifies concomitant posterior infarction and whether these patients benefit more from thrombolysis. |
| 21351226 | 2011 | Case report | Catheter Cardiovasc Interv | Primary PCI of an unprotected left main artery in posterolateral MI, facilitated by intracoronary reteplase. Alteplase was not used, so this is indirect evidence. |
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| BLA103172 | Cathflo Activase (Genentech, Inc.) | Injection, powder, lyophilized, for solution | Not stated in the source record |
Safety Considerations
Please refer to the package insert for safety information. No interaction records were found in the source data.
One point comes from the retrieved literature: the case report above describes systemic (cerebral) embolism during late fibrinolysis, so embolic risk should be part of any safety assessment.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is a subtype of an acute MI use rather than a distinct repurposing opportunity. No trials are registered, and the only literature is indirect (a case report, a PCI case with a different drug, and a diagnostic ECG study). The evidence level is L4. The package insert safety data is still missing, which blocks progression to safety screening.
To proceed, the following is needed:
- The US package insert (warnings, contraindications) and the approved-indication text for BLA103172
- Mechanism of action data from DrugBank
- Alteplase-specific data for posterolateral MI, such as subgroup analyses of major thrombolysis trials (e.g., TAMI-1 and GUSTO reported infarct-location or subgroup findings for rt-PA)
- A decision on whether posterolateral MI should be evaluated as part of the broader acute MI indication rather than as a separate candidate
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.