A Phase 3 interventional study of alteplase in Stroke, sponsored by Boehringer Ingelheim. Completed at 11 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
To evaluate the safety and efficacy of alteplase when administered between 3 and 4.5 hours after onset of stroke symptoms in Chinese patients with acute ischemic stroke
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 120 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
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Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
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Age >= 18 years at screening(visit 1A) but \<= 80 years Signed and dated written informed consent in accordance with good clinical practice and local legislation prior to admission to the trial Diagnosis of ischemic stroke with a measureable neurological deficit on National Institute of Health Stroke Scale (NIHSS) Thrombolytic therapy can be initiated within 3 to 4.5 hours of stroke onset Further inclusion criteria apply
Exclusion criteria:
Evidence of intracranial haemorrhage (ICH) on the (Computer Tomography) CT/(Magnetic Resonance Imaging)MRI-scan or symptoms suggestive of subarachnoid haemorrhage, even if the CT/MRI-scan is normal Acute bleeding diathesis Severe stroke as assessed clinically( e.g. National Institute of Health Stroke Scale>25) and/ or imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere) Severe uncontrolled arterial hypertension, e.g. systolic blood pressure>185 mmHg or diastolic blood pressure>110mmHg, or aggressive management (intravenous medication) necessary to reduce blood pressure to these limits Blood glucose \<50mg/ dL or >400 mg/dL Any history of prior stroke in previous 3 months, or any history of prior stroke with concomitant diabetes Seizure at stroke onset Further exclusion criteria apply
Drug: alteplase
The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient
The percentage of patients with modified Rankin Scale (mRS 0-1) (favourable outcome) response at Visit 5 (Day 90) after stroke onset by face-to-face interview with patient. Modified Rankin Scale (mRS): 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead.
Time frame: 90 days
The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period
The percentage of patients with symptomatic intracranial haemorrhage (sICH) centrally evaluated by data-monitoring committee (DMC) consultants according to European Cooperative Acute Stroke Study (ECASS) III definition within the whole study period. According to the protocol, sICH (ECASS III criteria) was defined as: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration (defined by an increase in the NIHSS score of 4 or more points), or that led to death and that was identified as the predominant cause of the neurological deterioration. sICH event was firstly evaluated by investigator. The DMC consultants evaluated all the patients with NIHSS score increase of at least 4 any time after treatment (including all fatal patients and sICH events evaluated by investigator). Wilson score confidence interval is presented.
Time frame: 90 days
The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1
Percentage of global outcome responder at day 90 if he/she obtains the following results at day 90 for the endpoints mRS score of 0 to 1; Barthel Index score \>= 95; NIHSS score of 0 to 1; Glasgow Outcome Scale score of 1. mRS: 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead. NIHSS is composed of 11 items, and for each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Glasgow Outcome Score applies to patients with brain damage allowing the objective assessment of their recovery in five categories: 1 Good Recovery, 2 Moderately Disabled, 3 Severely Disabled, 4 Vegetative State, 5 Dead. Barthel Index score to measure performance in activities of daily living with the scale ranging from 0 to 100. Global outcome response is the intersection of above four respective outcomes.
Time frame: 90 days
Patient Survival Probability at Visit 5 (Censoring at Day 90)
Patient survival probability at visit 5 (censoring at day 90). The percentage of patients who died until Day 1, Day 7, Day 30, Day 90.
Time frame: 90 days
The Percentage of Patients With Death Related to Stroke or of Neurological Causes
The percentage of patients with death related to stroke or of neurological causes.
Time frame: 90 days
The Percentage of Patients With Severity of Adverse Events
The percentage of patients with severity of adverse events (AEs). The percentage of patients with different categories of AEs are presented.
Time frame: On-treatment period, that is, within 7 days from the start of bolus
The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema
The percentage of patients with incidence of cerebral herniation and symptomatic edema.
Time frame: 90 days
A total of 121 patients were screened from 11 centres across China. Of the screened patients, 1 patient did not meet the study entry criteria. The first patient visit was on 12 December 2016 and the last patient visit was on 11 December 2017.
| Milestone | Alteplase (Rt-PA) |
|---|---|
| Started | 120 |
| Completed | 108 |
| Not completed | 12 |
| Withdrew: Adverse event | 6 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Withdrawal by subject | 1 |
The percentage of patients with modified Rankin Scale (mRS 0-1) (favourable outcome) response at Visit 5 (Day 90) after stroke onset by face-to-face interview with patient. Modified Rankin Scale (mRS): 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead.
| Percentage of patients | Alteplase (Rt-PA) |
|---|---|
| No symptom at all | 42.5 |
| No sign. disability | 20.8 |
| Slight disability | 8.3 |
| Moderate disability | 14.2 |
| Moderate Severe disability | 1.7 |
| Severe disability | 7.5 |
| Dead | 5.0 |
Percentage of global outcome responder at day 90 if he/she obtains the following results at day 90 for the endpoints mRS score of 0 to 1; Barthel Index score \>= 95; NIHSS score of 0 to 1; Glasgow Outcome Scale score of 1. mRS: 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead. NIHSS is composed of 11 items, and for each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Glasgow Outcome Score applies to patients with brain damage allowing the objective assessment of their recovery in five categories: 1 Good Recovery, 2 Moderately Disabled, 3 Severely Disabled, 4 Vegetative State, 5 Dead. Barthel Index score to measure performance in activities of daily living with the scale ranging from 0 to 100. Global outcome response is the intersection of above four respective outcomes.
| Percentage of patients | Alteplase (Rt-PA) |
|---|---|
| Global outcome response | 55.0 (46.08 to 63.61) |
| A response of 0 or 1 on mRS | 63.3 (54.42 to 71.42) |
| A response of least 95 on the Barthel index score | 65.8 (56.97 to 73.71) |
| A response of 0 or 1 on NIHSS | 56.7 (47.73 to 65.19) |
| A Glasgow outcome of 1 | 69.2 (60.42 to 76.73) |
The percentage of patients with symptomatic intracranial haemorrhage (sICH) centrally evaluated by data-monitoring committee (DMC) consultants according to European Cooperative Acute Stroke Study (ECASS) III definition within the whole study period. According to the protocol, sICH (ECASS III criteria) was defined as: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration (defined by an increase in the NIHSS score of 4 or more points), or that led to death and that was identified as the predominant cause of the neurological deterioration. sICH event was firstly evaluated by investigator. The DMC consultants evaluated all the patients with NIHSS score increase of at least 4 any time after treatment (including all fatal patients and sICH events evaluated by investigator). Wilson score confidence interval is presented.
| Percentage of patients | Alteplase (Rt-PA) |
|---|---|
| Day 0-1 | 2.5 (0.85 to 7.09) |
| Day 2-7 | 0.0 (NA to NA) |
| Day 8-30 | 0.0 (NA to NA) |
| Day 31-90 | 0.0 (NA to NA) |
| Day>90 | 0.0 (NA to NA) |
Patient survival probability at visit 5 (censoring at day 90). The percentage of patients who died until Day 1, Day 7, Day 30, Day 90.
| Percentage of patients | Alteplase (Rt-PA) |
|---|---|
| Day 0-1 | 0.0 |
| Day 2-7 | 3.3 |
| Day 8-30 | 1.7 |
| Day 31-90 | 0.0 |
The percentage of patients with death related to stroke or of neurological causes.
| Percentage of patients | Alteplase (Rt-PA) |
|---|---|
| The Percentage of Patients With Death Related to Stroke or of Neurological Causes | 4.2 (1.79 to 9.38) |
The percentage of patients with severity of adverse events (AEs). The percentage of patients with different categories of AEs are presented.
| Percentage of patients | Alteplase (Rt-PA) |
|---|---|
| Any AE | 85.8 |
| Severe AE | 20.8 |
| Investigator defined drug-related AEs | 12.5 |
| AEs leading to discontinuation of study drug | 0.0 |
| Serious AEs | 10.0 |
| Results in death | 4.2 |
| Immediately life threatening | 3.3 |
| Persistent or significant disability/ incapacity | 1.7 |
| Required/prolonged hospitalization | 5.0 |
| Congenital anomaly/ birth defect | 0.0 |
| Other comparable medical criteria | 0.0 |
The percentage of patients with incidence of cerebral herniation and symptomatic edema.
| Percentage of patients | Alteplase (Rt-PA) |
|---|---|
| The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema | 4.2 (1.79 to 9.38) |
Collected over Serious and Other Adverse Events (AEs): From the administration of trial medication until 7 days, up to 7 days. All-Cause Mortality: From the administration of trial medication until 100 days, up to 100 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alteplase (Rt-PA) | 7/120 (5.8%) | 12/120 (10%) | 72/120 (60%) |
| Event | Alteplase (Rt-PA) |
|---|---|
| Haemorrhage intracranialNervous system disorders | 3/120 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 3/120 |
| Brain herniationInjury, poisoning and procedural complications | 2/120 |
| Acute left ventricular failureCardiac disorders | 1/120 |
| Cerebral haemorrhageNervous system disorders | 1/120 |
| Cerebral infarctionNervous system disorders | 1/120 |
| Stroke in evolutionNervous system disorders | 1/120 |
| Event | Alteplase (Rt-PA) |
|---|---|
| ConstipationGastrointestinal disorders | 22/120 |
| HypokalaemiaMetabolism and nutrition disorders | 15/120 |
| HyperhomocysteinaemiaMetabolism and nutrition disorders | 15/120 |
| Lung infectionInfections and infestations | 10/120 |
| PneumoniaInfections and infestations | 10/120 |
| Hepatic function abnormalHepatobiliary disorders | 9/120 |
| PyrexiaGeneral disorders | 9/120 |
| HeadacheNervous system disorders | 9/120 |
| Vitamin B12 deficiencyMetabolism and nutrition disorders | 7/120 |
| Cerebral artery stenosisNervous system disorders | 7/120 |
Treated Set (TS) consisted of all enrolled patients who received study medication at any dose.
| Age, Continuous(Years) | Alteplase (Rt-PA) |
|---|---|
| Mean | 61.1 ± 10.85 |
| Sex: Female, Male(Participants) | Alteplase (Rt-PA) |
|---|---|
| Female | 24 |
| Male | 96 |
| Ethnicity (NIH/OMB)(Participants) | Alteplase (Rt-PA) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 120 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Alteplase (Rt-PA) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 120 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Baseline NIHSS(Unit on Scale) | Alteplase (Rt-PA) |
|---|---|
| Mean | 6.9 ± 4.68 |
| Baseline NIHSS by class(Participants) | Alteplase (Rt-PA) |
|---|---|
| 0-3 | 36 |
| 4-9 | 56 |
| 10-15 | 19 |
| 16-20 | 7 |
| >20 | 2 |
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Boehringer Ingelheim