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CompletedNCT04915729ORIGINALUpdated Dec 10, 2024Results posted

A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity

A Phase 3 interventional study of tenecteplase and alteplase in Stroke, sponsored by Boehringer Ingelheim. Completed at 55 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-10.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,489
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is open to Chinese adults who had an ischaemic stroke, which means that blood vessels in the brain are blocked. To resolve blood clots, people in the study get either tenecteplase or alteplase within 4 hours and 30 minutes after stroke. The purpose of this study is to compare how tenecteplase and alteplase improve peoples' recovering of physical activity. Alteplase is standard of care. Tenecteplase is a modified variant of alteplase that is easier to administer and is approved to treat heart attack. This study is to find out whether tenecteplase is as good as alteplase in people with ischaemic stroke.

Participants are equally put into 2 treatment groups by chance. Participants in one group get tenecteplase as a single injection into a vein. Participants in the other group get alteplase as an injection into a vein (10% of the dose) and the remainder as an infusion over 1 hour.

Participants are in the study for about 3 months. They are in the hospital for the first week after treatment. Then they visit the study site 1 and 3 months after treatment. At these visits, peoples' ability to independently carry out daily activities is assessed. Scores for physical activity are compared between both treatment groups. The doctors also regularly check the general health of the participants.

02

Conditions studied

  • Stroke

Browse trials for

03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 1,489 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥18 years old
  • Diagnosis of ischaemic stroke with a measurable neurological deficit on National Institutes of Health Stroke Scale (NIHSS) (0\< NIHSS ≤25); if NIHSS \<4, patients have to be with at least a measurable deficit on motor power (upper or lower limbs ≥1)
  • Stroke symptoms should have been present for at least 30 minutes (min) without significant improvement prior to randomisation
  • Thrombolytic therapy can be initiated within 4.5 Hour(s) (h) of Acute ischaemic stroke (AIS) onset
  • Patients with premorbid modified Rankin Scale (mRS) 0 or 1
  • Signed and dated written informed consent in accordance with good clinical practice (GCP) and local legislation prior to trial admission

Exclusion criteria

Exclusion Criteria:

  • Evidence of intracranial haemorrhage on the Computed tomography (CT) scan or symptoms suggestive of subarachnoid haemorrhage, even if the CT scan is normal
  • Patients who must or are expected to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial

  • Acute bleeding diathesis, including but not limited to

    • Known genetic predisposition to bleeding or significant bleeding disorder at present or within the past 6 Month(s) (m)
    • Administration of heparin within the previous 48 h and activated partial thromboplastin time (aPTT) exceeding the upper limit of normal for laboratory measurement
    • Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (International normalised Ratio (INR) > 1.7 or Prothrombin time (PT)>15 seconds (s)) or current use of novel oral anticoagulants (i.e. dabigitran, rivaroxiban, or apixiban) with prolongation of activated partial thromboplastin time (aPTT) and/or PT above the upper limit of the local laboratory reference range
    • Platelet count of below 100,000/mm3 at screening
    • Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
    • Recent traumatic external heart massage, obstetrical delivery, or recent puncture of a non-compressive blood-vessel (e.g. subclavian or jugular vein puncture) , within the past 10 days
    • Known history of suspected intracranial haemorrhage or suspected subarachnoid haemorrhage from aneurysm
    • Neoplasm with increased haemorrhagic risk
    • Documented ulcerative gastrointestinal disease during the last 3 m, oesophageal varices, arterial aneurysm, or arterial/venous malformations
    • Any known disorder associated with a significant increased risk of bleeding
  • Bacterial endocarditis or pericarditis at screening
  • Acute pancreatitis at screening
  • Significant trauma or major surgery (according to the investigator's assessment) in the past 3 m
  • Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere)
  • Severe uncontrolled arterial hypertension, e.g. systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg Further exclusion criteria apply.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,489 participants (actual)

Study arms

  • Experimental
    Tenecteplase treatment group

    Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of tenecteplase, 0.25 mg/kg via intravenous (iv) bolus no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patient performed a 90-day follow-up visit after the treatment to complete the study.

    Drug: tenecteplase

  • Active comparator
    Alteplase active control group

    Chinese patients with AIS were screened (visit 1) and randomised (visit 2a) when admitted. Patients received a single dose of alteplase, 0.9 mg/kg, 10% via intravenous (iv) bolus and the remaining 90% of the total dose administered as an iv infusion over 1 h no later than 4.5 hours (h) after symptom onset. Visits on Day 1 consisted of two further visits (Visit 2b and Visit 2c) that were performed 1 h and 2 h after the start of the treatment. Visits 3 to 5 for continuous follow-up were performed on day 2, 8 and 30 after the start of the treatment. Treated patient performed a 90-day follow-up visit after the treatment to complete the study.

    Drug: alteplase

Interventions

  • Drugtenecteplase

    tenecteplase

  • Drugalteplase

    alteplase

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1

    Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

    Time frame: At Day 90±7 days

Secondary outcomes

  1. Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline

    Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Mild strokes (NIHSS \< 6): High likelihood of good recovery and independence, Moderate strokes (NIHSS 6-15): Variable outcomes depending on timely intervention, Severe strokes (NIHSS \> 15): Lower likelihood of recovery without significant disability and higher risk of mortality. Percentages are rounded to the nearest digits.

    Time frame: At 24 hours

  2. Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2

    Percentage of participants with Modified Rankin Scale (mRS) score of 0-2 is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

    Time frame: At Day 90

  3. Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score

    Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Restricted maximum likelihood (REML) based MMRM approach used to compare change from baseline in NIHSS score at day 90. If patient misses visit, missing data will not be imputed. The mixed effect model will handle missing data based on a likelihood method under MAR assumption. Change in NIHSS score from baseline = overall mean + treatment + visit + baseline NIHSS + age + time to drug administration since onset of stroke symptoms + treatment by visit interaction + baseline NIHSS by visit interaction + random error.

    Time frame: At baseline and at Day 90

  4. Distribution of Modified Rankin Scale (mRS)

    Distribution of Modified Rankin Scale (mRS) is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90.

    Time frame: At Day 90

  5. Percentage of Participants With Barthel Index Score ≥95

    The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome. Percentages are rounded to the nearest digits.

    Time frame: up to 90 days

  6. Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment Period

    Percentage of participants with Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) Ⅲ definition during on-treatment period is presented. Percentages are rounded to the nearest digits.

    Time frame: Up to 7 days.

  7. Percentage of Participants Who Died by Day 90

    Percentage of participants who died by day 90 is presented. Percentages are rounded to the nearest digits.

    Time frame: up to 90 days

  8. Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6

    Percentage of participants with Modified Rankin Scale (mRS) score of 5 or 6 is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

    Time frame: At Day 90

07

Results

Posted Dec 10, 2024

Participant flow

The main objective of this multi-centre, prospective, randomised, open label, blinded endpoint (PROBE), active-controlled parallel group phase III trial was to assess whether tenecteplase was non-inferior to alteplase in favourable outcome in Chinese patients with acute ischaemic stroke (AIS) who were eligible for intravenous (i.v.) thrombolysis within 4.5 h of symptom onset.

Participant flow — Overall Study
MilestoneTenecteplase Treatment GroupAlteplase Active Control Group
Started744745
Treated733735
Completed671675
Not completed7370
Withdrew: Lost to follow-up2010
Withdrew: Withdrawal by subject125
Withdrew: Death3444
Withdrew: Not treated36
Withdrew: Investigator removed subject12
Withdrew: Questionnaire result not evaluated10
Withdrew: Refuse of hospital visit13
Withdrew: Subject withdrew10

Outcome measures

PrimaryPercentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1

Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

Time frame:
At Day 90±7 days
Reported as:
Number · Percentage of participants
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
Percentage of participantsTenecteplase Treatment GroupAlteplase Active Control Group
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 172.770.3
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Modified Possion Regression Model · Risk ratio (rr): 1.0278 · 95% CI 0.9678 to 1.0915tenecteplase versus alteplase
SecondaryPercentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline

Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Mild strokes (NIHSS \< 6): High likelihood of good recovery and independence, Moderate strokes (NIHSS 6-15): Variable outcomes depending on timely intervention, Severe strokes (NIHSS \> 15): Lower likelihood of recovery without significant disability and higher risk of mortality. Percentages are rounded to the nearest digits.

Time frame:
At 24 hours
Reported as:
Number · Percentage of participants
Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline
Percentage of participantsTenecteplase Treatment GroupAlteplase Active Control Group
Percentage of Participants With Major Neurological Improvement (National Institutes of Health Stroke Scale (NIHSS) Score of 0 or Improvement of at Least 4 Points Compared With Baseline48.045.0
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Regression, Linear · p = 0.2412 (p-value was for superiority testing) · Risk ratio (rr): 1.0671 · 95% CI 0.9573 to 1.1895tenecteplase versus alteplase
SecondaryPercentage of Participants With Modified Rankin Scale (mRS) Score of 0-2

Percentage of participants with Modified Rankin Scale (mRS) score of 0-2 is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

Time frame:
At Day 90
Reported as:
Number · Percentage of participants
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2
Percentage of participantsTenecteplase Treatment GroupAlteplase Active Control Group
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-280.979.9
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Regression, Linear · p = 0.7480 (p-value was for superiority testing) · Risk ratio (rr): 1.0078 · 95% CI 0.9614 to 1.0564tenecteplase versus alteplase
SecondaryChange From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score

Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits. indivudal domains: level of consciousness (LOC), best gaze, visual fields, facial paresis, motor function arms, motor function legs, limb ataxia, sensory, language, dysarthria, extinction and inattention. Restricted maximum likelihood (REML) based MMRM approach used to compare change from baseline in NIHSS score at day 90. If patient misses visit, missing data will not be imputed. The mixed effect model will handle missing data based on a likelihood method under MAR assumption. Change in NIHSS score from baseline = overall mean + treatment + visit + baseline NIHSS + age + time to drug administration since onset of stroke symptoms + treatment by visit interaction + baseline NIHSS by visit interaction + random error.

Time frame:
At baseline and at Day 90
Reported as:
Least squares mean · score on a scale
Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score
score on a scaleTenecteplase Treatment GroupAlteplase Active Control Group
Change From Baseline of National Institutes of Health Stroke Scale (NIHSS) Score-3.47 ± 0.34-3.02 ± 0.34
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Mixed Models Analysis · p = 0.3511 · Mean difference (final values): -0.45 · 95% CI -1.40 to 0.50Difference in LSmean tenecteplase vs alteplase
SecondaryDistribution of Modified Rankin Scale (mRS)

Distribution of Modified Rankin Scale (mRS) is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90.

Time frame:
At Day 90
Reported as:
Number · Percentage of participants
Distribution of Modified Rankin Scale (mRS)
Percentage of participantsTenecteplase Treatment GroupAlteplase Active Control Group
mRS score = 040.340.5
mRS score = 130.128.2
mRS score = 27.89.4
mRS score = 36.75.5
mRS score = 44.86.4
mRS score = 51.91.6
mRS score = 64.66.0
missing3.82.3
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Regression, Logistic · p = 0.4806 · Odds ratio (or): 1.0418tenecteplase versus alteplase
SecondaryPercentage of Participants With Barthel Index Score ≥95

The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome. Percentages are rounded to the nearest digits.

Time frame:
up to 90 days
Reported as:
Number · Percentage of participants
Percentage of Participants With Barthel Index Score ≥95
Percentage of participantsTenecteplase Treatment GroupAlteplase Active Control Group
Percentage of Participants With Barthel Index Score ≥9575.773.9
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Regression, Linear · p = 0.5116 · Risk ratio (rr): 1.0189 · 95% CI 0.9635 to 1.0774tenecteplase versus alteplase
SecondaryPercentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment Period

Percentage of participants with Symptomatic Intracerebral Haemorrhage (sICH) per European Cooperative Acute Stroke Study (ECASS) Ⅲ definition during on-treatment period is presented. Percentages are rounded to the nearest digits.

Time frame:
Up to 7 days.
Reported as:
Number · Percentage of participants
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment Period
Percentage of participantsTenecteplase Treatment GroupAlteplase Active Control Group
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) Per European Cooperative Acute Stroke Study (ECASS) Ⅲ Definition During On-treatment Period1.21.2
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Suissa-Shuster test · p = 1.000 · Risk ratio (rr): 1.005 · 95% CI 0.370 to 2.701tenecteplase versus alteplase
SecondaryPercentage of Participants Who Died by Day 90

Percentage of participants who died by day 90 is presented. Percentages are rounded to the nearest digits.

Time frame:
up to 90 days
Reported as:
Number · Percentage of participants
Percentage of Participants Who Died by Day 90
Percentage of participantsTenecteplase Treatment GroupAlteplase Active Control Group
Percentage of Participants Who Died by Day 904.65.8
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Chi-squared · p = 0.303 · Risk ratio (rr): 0.795 · 95% CI 0.513 to 1.232tenecteplase versus alteplase
SecondaryPercentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6

Percentage of participants with Modified Rankin Scale (mRS) score of 5 or 6 is presented. Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death). It was measured at Day 90. Percentages are rounded to the nearest digits.

Time frame:
At Day 90
Reported as:
Number · Percentage of participants
Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6
Percentage of participantsTenecteplase Treatment GroupAlteplase Active Control Group
Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 66.87.8
Statistical analysis
  • Tenecteplase Treatment Group vs Alteplase Active Control Group · Regression, Linear · p = 0.6345 (p-value was for superiority testing) · Risk ratio (rr): 0.9215 · 95% CI 0.6578 to 1.2908tenecteplase versus alteplase

Adverse events

Collected over AEs are reported for the on-treatment period from start of treatment until end of residual effect period, up to 7 days. All cause mortality was reported from start of treatment until death by any cause, up to 97 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alteplase Active Control Group44/736 (6%)115/736 (15.6%)347/736 (47.1%)
Tenecteplase Treatment Group34/732 (4.6%)116/732 (15.8%)334/732 (45.6%)
Most frequent serious events
Showing 10 of 76
Most frequent serious events
EventAlteplase Active Control GroupTenecteplase Treatment Group
Cerebral haemorrhageNervous system disorders21/73625/732
Cerebral infarctionNervous system disorders14/73616/732
Haemorrhagic transformation strokeNervous system disorders16/73610/732
Deep vein thrombosisVascular disorders13/7368/732
Cardiac failureCardiac disorders8/7368/732
Brain herniationInjury, poisoning and procedural complications8/7367/732
PneumoniaInfections and infestations7/7367/732
Respiratory failureRespiratory, thoracic and mediastinal disorders3/7367/732
Haemorrhage intracranialNervous system disorders7/7365/732
Haemorrhagic cerebral infarctionNervous system disorders7/7363/732
Most frequent other events
Most frequent other events
EventAlteplase Active Control GroupTenecteplase Treatment Group
ConstipationGastrointestinal disorders123/736131/732
Gingival bleedingGastrointestinal disorders78/73679/732
HypokalaemiaMetabolism and nutrition disorders77/73670/732
PneumoniaInfections and infestations65/73655/732
Urinary tract infectionInfections and infestations49/73644/732
HyperhomocysteinaemiaMetabolism and nutrition disorders45/73644/732
PyrexiaGeneral disorders43/73633/732
HypoproteinaemiaMetabolism and nutrition disorders41/73632/732
AnaemiaBlood and lymphatic system disorders37/73632/732

Baseline characteristics

Full Analysis Set (FAS): This patient set included all randomised patients who received any dose of treatment. Treatment assignment was as randomised. This was the primary analysis set for presentation of efficacy according to the intention-to-treat principle.

Age, Continuous
Age, Continuous(Years)Tenecteplase Treatment GroupAlteplase Active Control GroupTotal
Mean65.1 ± 11.165.0 ± 11.165.0 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Tenecteplase Treatment GroupAlteplase Active Control GroupTotal
Female215231446
Male5175021019
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Tenecteplase Treatment GroupAlteplase Active Control GroupTotal
Hispanic or Latino000
Not Hispanic or Latino7327331465
Unknown or Not Reported000
National Institutes of Health Stroke Scale (NIHSS) class 1 at baseline
National Institutes of Health Stroke Scale (NIHSS) class 1 at baseline(Participants)Tenecteplase Treatment GroupAlteplase Active Control GroupTotal
NIHSS total score <6299297596
NIHSS total score 6 - 15390393783
NIHSS total score >=15434386
08

Study locations

55 sites
  • Inner Mongolia Baogang Hospital
    Baotou, 14000, China
  • Beijing Chao-Yang Hospital
    Beijing, 100020, China
  • Beijing Tsinghua Changgung Hospital
    Beijing, 100044, China
  • Beijing Tiantan Hospital affiliated to Cap Med University
    Beijing, 100070, China
  • Beijing Tongren Hospital
    Beijing, 100730, China
  • The First Hospital of Jilin University
    Changchun, 130031, China
  • The third xiangya hospital of Central South University
    Changsha, 410013, China
  • Hexigten Banner Mongolian Traditional Chinese medicine hospital
    Chifeng, 025350, China
  • Second Affiliated Hospital Chongqing Medical University
    Chongqing, 400016, China
  • Center Hospital of Dalian
    Dalian, 116021, China
  • Daqing People's Hospital
    Daqing, 163000, China
  • Shengli Oilfield central hospital
    Dongying, 257091, China
  • Third Affiliated Hospital of Guangzhou Medical University
    Guangzhou, 510150, China
  • The Affiliated Hospital of Guizhou Medical University
    Guiyang, 550004, China
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, 310009, China
  • Zhejiang Province People's Hospital
    Hangzhou, 310014, China
  • The Affiliated Hospital of Hangzhou Normal University
    Hangzhou, 310015, China
  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
    Hangzhou, 310016, China
  • Huai'an Second People's Hospital
    Huai'an, 223002, China
  • The First Affiliated Hospital of Baotou Medical College
    Inner Mongolia, 014010, China
  • The second Hospital of Jiaxing
    Jiaxing, 314001, China
  • Center Hospital of Jinan
    Jinan, 250013, China
  • Jinhua Municipal Central Hospital
    Jinhua, 321000, China
  • The first People's Hospital of Lianyungang
    Lianyungang, 222002, China
  • Linfen Central Hospital
    Linfen, 041000, China
  • Linyi People's Hospital
    Linyi, 276000, China
  • The First People's Hospital of Tancheng County
    Linyi, 276000, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, 330006, China
  • Zhongda Hospital Southeast University
    Nanjing, 210009, China
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, 210011, China
  • The First People's Hospital of Nanning
    Nanning, 530000, China
  • The First People's Hospital of Nantong
    Nantong, 226001, China
  • Ruian People's Hospital
    Ruian, 325200, China
  • Tongren hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, 200051, China
  • Tongji Hospital, Tongji University
    Shanghai, 200065, China
  • Shanghai East Hospital
    Shanghai, 200120, China
  • Shanghai Seventh People's Hospital
    Shanghai, 200137, China
  • Affiliated Central Hospital of Shenyang Medical College
    Shenyang, 110000, China
  • The First People's Hospital of Shenyang
    Shenyang, 110000, China
  • Peking University Shenzhen Hospital
    Shenzhen, 518000, China
  • The Second Hospital of Hebei Medical University
    Shijiazhuang, 050000, China
  • The Second Affiliated Hospital of Soochow University
    Suzhou City, 215004, China
  • Taizhou Hospital of Zhejiang Province
    Taizhou, 317099, China
  • The 2nd Hospital of Tianjin Medical University
    Tianjin, 300000, China
  • The First Center Hospital of Tianjin
    Tianjin, 300192, China
  • Tianjin Medical University General Hospital
    Tianjin, 30052, China
  • Wuhan Union Hospital
    Wuhan, 430022, China
  • Wuxi People's Hospital
    Wuxi, 214043, China
  • Xianyang Hospital of Yan'an University
    Xianyang, 712000, China
  • Xinxiang Central Hospital
    Xinxiang, 453000, China
  • The People's Hospital Of Xuancheng City
    Xuancheng, 242000, China
  • Affiliated Hospital, Xuzhou Medical college
    Xuzhou, 221006, China
  • Affiliated Hospital of Yangzhou University
    Yangzhou, 225001, China
  • Yantai Yuhuangding Hospital
    Yantai, 264010, China
  • Yiyang Central Hospital
    Yiyang, 413000, China
09

References and documents

Related links

Study documents

  • Study protocol · Feb 23, 2023
  • Statistical analysis plan · Sep 6, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Supporting information: Study protocol, Sap, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04915729
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jun 7, 2021
Start date
Jun 22, 2021
Primary completion
Oct 8, 2023
Completion
Oct 8, 2023
Results posted
Dec 10, 2024
Last update
Dec 10, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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