Table of Contents
- Overview of Alteplase research
- Stroke trials
- Pulmonary embolism trials
- Other conditions being studied
- Main outcomes used in the trials
- Trial phases and study size
- Who the trials are meant for
Overview of Alteplase research
The trial data show that Alteplase is being studied in several different clinical settings, mostly where fast treatment may affect recovery or survival.[1] The studies are mainly interventional trials, which means researchers assign treatments and then measure the results.[1] Most of the listed studies are in Phase 3, with a smaller number in Phase 2.[1]
Stroke trials
Many of the Alteplase trials focus on acute ischemic stroke, which is a stroke caused by a blocked blood vessel in the brain.[3] These studies look at different ways to use Alteplase, such as intravenous treatment, intra-arterial treatment, or treatment given after another procedure like mechanical thrombectomy.[3][4]
One Phase 3 study, SIFT, compares early neurological improvement in patients with acute ischemic stroke who are on factor Xa inhibitors, which are blood-thinning medicines.[3] Its main endpoint is early neurological improvement, measured by the NIHSS, a score that shows how severe stroke symptoms are.[3]
The CHOICE2TRIAL studies whether rt-PA is helpful as an add-on to mechanical thrombectomy in acute ischemic stroke when blood flow has already been mostly restored.[4] Its main outcome is the proportion of patients with mRS 0 to 1 at 90 days, which means little or no disability.[4]
Another Phase 3 trial tests intra-arterial t-PA during mechanical thrombectomy in people with large vessel occlusion of the anterior circulation.[7] This study also uses the mRS at 90 days to see whether patients do better functionally after treatment.[7]
The STROACT study looks at patients with acute ischemic stroke who take direct oral anticoagulants and have had their anticoagulant effect reversed with a specific antidote before thrombolysis.[6] It measures thrombotic events, death, and the mRS at 90 days, so it is studying both safety and recovery.[6]
The DO-IT trial also studies stroke in people with recent direct oral anticoagulant use and compares a thrombolysis strategy using Alteplase or tenecteplase with standard care.[8] Its main outcome is the mRS at 90 days, using a shift analysis, which means researchers look at the full spread of disability scores rather than only one cutoff.[8]
Other stroke trials include a study in basilar artery occlusion, where Alteplase is compared with tenecteplase and standard care, and a study in ischemic stroke that tests functional outcome after acute subcutaneous semaglutide with Alteplase in the background treatment list.[5][9] There is also a trial in ischemic stroke that studies Alteplase after successful reperfusion, meaning after blood flow has already been reopened.[10]
Pulmonary embolism trials
Several studies investigate Alteplase in pulmonary embolism, which is a blood clot in the lung.[11][12] These trials focus on people with intermediate-high-risk disease, meaning the clot is serious enough to need close study but not always the most severe form.[11][12]
PEITHO-3 tests whether a reduced dose of thrombolytic treatment can improve outcomes at 30 days in intermediate-high-risk acute pulmonary embolism.[11] Its main endpoint is a composite outcome: death, hemodynamic decompensation, or recurrent pulmonary embolism.[11]
STRATIFY II compares thrombus reduction across different treatment approaches, including catheter-based low-dose Alteplase, embolectomy, and heparin-based treatment.[12] The main measure is the modified Miller score, which reflects how much clot is present and how well blood flows through the lung vessels.[12]
Another Phase 3 study of catheter-directed thrombolysis compares clinical outcomes such as death, recurrent pulmonary embolism, and cardiorespiratory collapse within 7 days.[13] This trial is focused on short-term safety and early clinical stability.[13]
Other conditions being studied
Alteplase is also being studied in frostbite injury to extremities, where severe cold damages fingers, toes, hands, or feet.[1] The trial compares Alteplase with iloprost in severe frostbite and looks at amputation rates and longer-term function.[1]
In eye disease, one Phase 3 study called TIGER tests surgery with subretinal TPA for submacular hemorrhage caused by wet age-related macular degeneration.[2] The main outcome is gaining at least 10 ETDRS letters in best corrected visual acuity at 12 months, which means better measured vision in the study eye.[2]
Alteplase is also being studied in pleural empyema and other pleural infections, which are infections in the space around the lungs.[9][14] One trial compares intrapleural fibrinolysis and DNase with surgery, while another compares early pleural irrigation with standard care and includes Alteplase among the treatment options used in practice.[9][14]
Main outcomes used in the trials
Most trials use outcomes that show whether patients recover well, avoid serious complications, or survive the illness.[1][2][3]
mRS: This scale measures disability after stroke. Lower scores mean better function and more independence.[3][4][5][6][7][8][10]
NIHSS: This score measures stroke severity and early improvement after treatment.[3]
Amputation rate: In frostbite research, this shows whether tissue loss can be reduced.[1]
Vision gain: In the eye trial, this measures whether treatment improves sight.[2]
Death and recurrence: In pulmonary embolism and pleural infection studies, these outcomes show whether treatment prevents serious harm or repeat illness.[11][13][14]
Trial phases and study size
Almost all of the listed studies are in Phase 3, which usually means the treatment is being tested in larger groups and compared with another treatment or standard care.[1][2][3][4][5][7][11][12][13][14]
Two trials are in Phase 2, including the STROACT study and the ASSET trial, which are earlier studies that often explore safety and early benefit.[6][9] Enrollment ranges from small studies of about 100 patients to large studies with more than 800 participants.[1][11][12]
Who the trials are meant for
The target populations are people with specific medical problems, not general healthy volunteers.[1] Most studies focus on adults with emergency conditions such as stroke, pulmonary embolism, or severe frostbite, while others focus on patients with eye bleeding or pleural infection.[1][2][11][14]
Some stroke studies have extra entry rules, such as recent use of direct oral anticoagulants, factor Xa inhibitors, or proof of successful reperfusion before the study treatment is given.[3][6][8][10] This means the trials are not all the same; each one is designed for a specific patient group and a specific clinical question.[1][2][3]
