An observational study in Stroke, sponsored by Boehringer Ingelheim. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Boehringer Ingelheim · Observational
The objective of the study is to find out the in-hospital clinical outcomes among Chinese Acute Ischaemic Stroke (AIS) patients, who were treated with intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) within 4.5 hours of symptom onset in different age groups (18 to 80 years and above 80 years).
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Acute ischemic stroke (AIS) patients who were treated with Intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) or did not receive thrombolysis treatment within 4.5 hours of symptom onset, aged ≥18 years old.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Group 1: Acute ischemic stroke (AIS) patients aged \>80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
Drug: rt-PA
Group 2: Acute ischemic stroke (AIS) patients aged 18 to 80 years who received intravenous recombinant tissue plasminogen activator (IV rt-PA) (Alteplase) within 4.5 hours of symptom onset.
Drug: rt-PA
Group 3: Acute ischemic stroke (AIS) patients aged \>80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.
Group 4: Acute ischemic stroke (AIS) patients aged 18 to 80 years who arrived or were admitted to the hospital within 4.5 hours of symptom onset and did not receive thrombolysis treatment.
Intravenous recombinant tissue plasminogen activator (IV rt-PA)
Also known as: Alteplase
All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients
All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).
Time frame: Up to 100 days.
Percentage of Patients With Hemorrhagic Stroke During Hospitalization
Percentage of patients with hemorrhagic stroke during hospitalization.
Time frame: Up to 100 days.
Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment
The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment.
Time frame: Up to 24 hours.
Modified Rankin Score (mRS) at Discharge
The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.
Time frame: Up to 100 days.
Number of Patients With Stroke Recurrence During Hospitalization
Number of patients with stroke recurrence during hospitalization.
Time frame: Up to 100 days.
Length of Hospitalization
Length of hospitalization.
Time frame: Up to 100 days.
Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset
Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset.
Time frame: Up to 4.5 hours.
Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission)
Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission).
Time frame: Up to 4.5 hours.
In this study the Chinese Stroke Centre Alliance (CSCA) data was used to describe the in-hospital clinical outcomes regarding safety and effectiveness for acute ischemic stroke (AIS) patients who were treated with intravenous recombinant tissue plasminogen activator (IV rt-PA) within 4.5 hours of symptom onset, aged above 80 years, as well as between 18 and 80 years.
| Milestone | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment |
|---|---|---|---|---|
| Started | 3332 | 28086 | 12533 | 69084 |
| Completed | 3332 | 28086 | 12533 | 69084 |
| Not completed | 0 | 0 | 0 | 0 |
All-cause mortality during hospitalization of acute ischemic stroke (AIS) patients who received intravenous recombinant tissue plasminogen activator (IV rt-PA).
| Percentage of participants | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) |
|---|---|---|
| All-cause Mortality During Hospitalization of Acute Ischemic Stroke (AIS) Patients | 2.6 (2.1 to 3.2) | 0.8 (0.7 to 0.9) |
Percentage of patients with hemorrhagic stroke during hospitalization.
| Percentage of subjects | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) |
|---|---|---|
| Percentage of Patients With Hemorrhagic Stroke During Hospitalization | 6.7 (5.8 to 7.5) | 3.1 (2.9 to 3.3) |
The National Institutes of Health Stroke Scale (NIHSS) is a scale of stroke severity, it ranges from 0 to 42 where a score of 0 indicates no stroke symptoms and higher scores indicate incremental levels of neurologcial impairment.
| Score on a scale | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) |
|---|---|---|
| Change of NIHSS Score From Before Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment to 24 Hours After IV Rt-PA Treatment | 2.8 ± 5.0 | 2.5 ± 4.3 |
The Modified Rankin Score (mRS) ranges from 0 to 6, where 0 indicates no symptoms, 1 no significant disability, 2 slight disability, 3 moderate disability, 4 moderately severe disability, 5 severe disability and 6 death.
| Participants | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) |
|---|---|---|
| mRS score 0 | 383 | 5447 |
| mRS score 1 | 612 | 6427 |
| mRS score 2 | 281 | 2131 |
| mRS score 3 | 216 | 1393 |
| mRS score 4 | 399 | 2163 |
| mRS score 5 | 346 | 902 |
| mRS score 6 | 88 | 211 |
Number of patients with stroke recurrence during hospitalization.
| Participants | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) |
|---|---|---|
| Number of Patients With Stroke Recurrence During Hospitalization | 369 | 2039 |
Length of hospitalization.
| days | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) |
|---|---|---|
| Length of Hospitalization | 12.7 ± 9.6 | 11.5 ± 7.6 |
Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment among acute ischemic stroke (AIS) patients arrived or were admitted to the hospital within 4.5 hours of symptom onset.
| Percentage of participants | Acute Ischemic Stroke (AIS) Patients Aged >80 Years | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years |
|---|---|---|
| Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Among Acute Ischemic Stroke (AIS) Patients Arrived or Were Admitted to the Hospital Within 4.5 Hours of Symptom Onset | 21.0 (20.4 to 21.6) | 28.9 (28.6 to 29.2) |
Percentage of intravenous recombinant tissue plasminogen activator (IV rt-PA) treatment within 4.5 hours of symptom onset among eligible AIS patients (3.5-hour arrival or admission).
| Percentage of participants | Acute Ischemic Stroke (AIS) Patients Aged >80 Years | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years |
|---|---|---|
| Percentage of Intravenous Recombinant Tissue Plasminogen Activator (IV Rt-PA) Treatment Within 4.5 Hours of Symptom Onset Among Eligible AIS Patients (3.5-hour Arrival or Admission) | 23.9 (23.2 to 24.6) | 32.2 (31.8 to 32.5) |
Collected over Adverse event information was not applicable for this study. All-cause mortality was only collected and reported for group 1 and group 2 for up to 100 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | 88/3,332 (2.6%) | — | — |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | 211/28,086 (0.8%) | — | — |
| Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | — | — | — |
| Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | — | — | — |
Patients registered in the Chinese Stroke Centre Alliance (CSCA) platform from August 2015 to July 2019 with an acute ischemic stroke (AIS) diagnoses at admission.
| Age, Continuous(years) | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | Total |
|---|---|---|---|---|---|
| Mean | 84.4 ± 3.2 | 63.2 ± 10.7 | 84.9 ± 3.4 | 64.2 ± 10.4 | 66.8 ± 12.2 |
| Sex: Female, Male(Participants) | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | Total |
|---|---|---|---|---|---|
| Female | 1710 | 9188 | 6418 | 24409 | 41725 |
| Male | 1622 | 18898 | 6115 | 44675 | 71310 |
| Race and Ethnicity Not Collected(Participants) | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Who Received IV Rt-PA (Alteplase) | Acute Ischemic Stroke (AIS) Patients Aged >80 Years Without Thrombolysis Treatment | Acute Ischemic Stroke (AIS) Patients Aged 18 to 80 Years Without Thrombolysis Treatment | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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