Minor StrokePhase 3TRUSTNCT04420351
Thrombolysis of Urokinase for Minor Stroke
A Phase 3 study testing Urokinase thrombolysis and Aspirin;Clopidogrel in people with Minor Stroke, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
This trial will enroll patients that have been diagnosed with minor stroke, which has occurred within the past 6 hours. TRUST is a prospective multicenter, randomized, blinded-endpoint study to evaluate the efficacy and safety of Urokinase Thrombolysis for patients with minor stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Minor Stroke
- What is being tested?
- Urokinase thrombolysis and Aspirin;Clopidogrel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,005 participants
- Where
- 1 siteChina
- Study dates
- 4 Oct 2020to 18 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients: 18-80 years old
- The time from last seen well to treatment < 6 hours
- Minor stroke defined as a baseline NIHSS ≤5 at the time of randomization..
- First onset or pre-stroke mRS≤1
- Informed consent signed
Who cannot join
- 1.Hyperdensity on CT suggesting intracranial hemorrhage
- 2.Large acute stroke >1/3 middle cerebral artery (MCA) territory visible on CT or MRI
- 3.Other contraindications of intravenous thrombolysis, including but not limited to:
- Intracranial tumor, arteriovenous malformation
- Coma or confirmed as severe stroke by clinical assessment (e.g. NIHSS ≥25) or proper imaging methods
- With seizure
Show all 31Show fewer
- Stroke attack within past three months
- Heparin administration within 48h before onset, with APTT longer than upper limit
- Stroke history with diabetes
- Platelet count ≤100×10^9/L
- Difficult to control hypertension, defined by systolic pressure ≥185mmHg or diastolic pressure ≥110 mmHg in 3 tests with at least ten minutes interval, under well guided medications.
- Blood glucose <50mg/dl（2.7mmol/l）or >400mg/dl（22.2mmol/l）
- Obvious hemorrhage within past 6 months
- Oral anti-coagulation drug administration (e.g. warfarin) with INR>1.5
- Intracranial hemorrhage or suspected intracranial hemorrhage (including subarachnoid hemorrhage)
- Pregnancy or lactation.
- History of severe CNS damage (e.g. tumor, arterial aneurysm or CNS surgery)
- Hemorrhagic retinopathy, e.g. diabetes (hemorrhages suggested by optic impairment) or other hemorrhagic ocular lesions.
- Bacterial endocarditis or pericarditis.
- Prolonged or traumatic CPR (>2min), puncture in nonstress vessels within past 10 days, such as subclavian vein puncture.
- Acute pancreatitis.
- Confirmed ulcerative gastric or intestinal problems within 3 months.
- Arterial aneurysm or arteriovenous malformation.
- Any tumor that increase risk of hemorrhage.
- Severe hepatic diseases, like hepatic failure, liver cirrhosis, portal hypertension, esophageal varices or active hepatitis.
- Major surgery, severe trauma or craniocerebral trauma within past 10 days.
- Allergy to any components of urokinase.
- 4.Severe, fatal diseases with less than 3 month expected survival.
- 5.Intended to receive standard rt-PA thrombolysis or intravascular therapy.
- 6.Already participating in other studies that conflict to this study.
- 7.Unable to accomplish the follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 0371
About this study
Official title: A Phase ⅢB, Prospective, Randomized, Open Label, Blinded-endpoint, Multicenter Trial of the Efficacy and Safety of Urokinase Thrombolysis Comparing With Antiplatelet Agents for Patients With Minor Stroke.
This trial will enroll patients that have been diagnosed with minor stroke, which has occurred within the past 6 hours. TRUST is a prospective multicenter, randomized, blinded-endpoint study to evaluate the efficacy and safety of Urokinase Thrombolysis for patients with minor stroke.
Read the detailed description
China is currently faced with the heaviest stroke burden due to the tremendous population and susceptibility to cerebrovascular disease. As has been assessed, deaths caused by cerebrovascular disease are three times of cardiovascular disease. Within whole population with cerebrovascular disease, minor stoke have taken a significant part of the disease burden. Thus the population with minor stoke is one of the most important parts in efficient prevention of cerebrovascular disease. According to phase I and II data from national stoke registration in China, 35.25% to 42.23% cases were minor ischemic strokes. However, in clinical practice, the minor ischemic stroke patients are likely to be ignored and some might have poor prognosis. As has been demonstrated by a number of studies, up to one third of the acute non-disabling ischemic stroke without in-time thrombolysis may suffer from disabling or death at 90-day follow-up.
Several studies have demonstrated the potential benefits of thrombolysis compared usually with placebo, including the Third International Stroke Trail ( IST-3, rt-PA to placebo, patients within 3 hours after attack, with blood pressure lower than 185/110mmHg and NIHSS≤5)，National Institute of Neurological Disorders and Stroke rt-PA Stroke Study（ NINDS, rt-PA to placebo, patients with mild ischemic stroke recognized by 5 different definitions）.
Urokinase is a kind of non-selective plasminogen activator, urokinase acted as effective catalyzer in the transferring of both free and protein-binding plasminogen to plasmin, thus inducing thrombolysis. As one of the widely used medication for intravenous thrombolysis in China, urokinase has been suggested the the efficacy and safety for ischemic stroke. With easier availability and lower price, urokinase has provided a promising alternation to patients who need thrombolysis in China, especially in less developed areas. The Chinese guideline for diagnosis and treatment of acute ischemic stroke 2018 has recommended urokinase as an alternation in the treatment of acute ischemic stroke within 6-hour time window as well, if rt-PA is not available or affordable. However, randomized and multicenter clinical trial of urokinase thrombolysis for minor stroke is still vacant, which couldn't provide more persuasive evidence.
TRUST is a prospective multicenter, randomized, single-blind evaluation study to evaluate the efficacy and safety of Urokinase Thrombolysis for patients with minor stroke. The trail will enroll a total of 1002 minor stroke patients within a 6 hour time window with a NIHSS score ≤5 at the time of randomization. Randomization will be 1:1 to Urokinase Thrombolysis (experimental) or Antiplatelet agents (control). Patients will receive 1 million units urokinase dissolved by 100ml saline through intravenous infusion within 30min or oral antiplatelet agents. All patients will undergo CT or MRI before treatment and will undergo the second CT within 36 hours after treatment. Patients will be followed up at 36h, 7d and 90 days. The primary outcome measures including the proportion of patients with a modified Rankin Scale(mRS) of 0 or 1 at 90-day follow-up and the patients with symptomatic intracranial hemorrhage within 36 hours. Secondary outcome measures cover new vascular events, the Progress of MRS score, Neurological impairment, Daily function evaluations, Quality of life assessments, Overall mortality and Adverse events and severe adverse events within 90 days.
- Conditions
- Minor Stroke
- Being tested
- Urokinase thrombolysis, Aspirin;Clopidogrel
- Keywords
- Thrombolysis, Urokinase, Ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urokinase thrombolysisDrug
Also called Urokinase
The patients of intervention group will receive 1 millions units urokinase dissolved by 100 saline through intravenous infusion within 30 minutes.
Aspirin;ClopidogrelDrug
Also called Antiplatelet treatment
The control group will receive antiplatelet agents as decided by the physicians according to Chinese guideline for diagnosis and treatment of acute ischemic stroke 2018.
| Study group | Role | What they receive |
|---|---|---|
| Urokinase thrombolysis | Experimental | The patients of intervention group will receive 1 millions units urokinase dissolved by 100 saline through intravenous infusion within 30 minutes. Receives: Drug: Urokinase thrombolysis |
| Antiplatelet treatment | Other | The control group will receive antiplatelet agents as decided by the physicians according to Chinese guideline for diagnosis and treatment of acute ischemic stroke 2018 Receives: Drug: Aspirin;Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a modified Rankin Scale(mRS) of 0 or 1 at 90-day follow-up
mRS has 0-6 points, the higher the worse outcome.
Measured: 90 Days
Proportion of patients with symptomatic intracranial hemorrhage within 36 hours
Symptomatic intracranial haemorrhage within 36 hours
Measured: 36 hours
Secondary outcomes (8)
Proportion of patients with new vascular events
Proportion of patients with new vascular events within 90 days(Ischemic stroke / hemorrhagic stroke / TIA / myocardial infarction / vascular death)
Measured: 90 days
MRS score
To evaluate the progress of MRS score
Measured: 90 days
The ratio of patients with MRS 0-1 during the last visit in two groups
mRS has 0-6 points, the higher the worse outcome.
Measured: 90 days
Changes in National Institutes of Health Stroke Scale(NIHSS) score
Neurological impairment in two groups (changes in NIHSS score at 90-day follow-up). NIHSS has 0-42 points, the higher the worse outcome.
Measured: 90 days
Barthel index (BI) score
Daily function evaluations(BI score at 90 days). BI has 0-100 points,the higher the bettter outcome.
Measured: 90 days
Quality of life assessments
EuroQol five dimensional questionnaire (EQ-5D scale).
Measured: 90 days
Overall mortality
Overall mortality within 90 days
Measured: 90 days
Adverse events and severe adverse events
Adverse events and severe adverse events in two groups during 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start4 Oct 2020
- Primary completion18 Feb 2023
- Study completion18 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Minor StrokeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Shanghai 10th People's Hospital, General Hospital of Shenyang Military Region
- Responsible party
- Principal investigator, Bo Song, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Bo Song, MD;PhD, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420351
- Sponsor's protocol ID
- 2017YFC1308202
- Acronym
- TRUST
- Status last verified
- Nov 2023
- First submitted
- 4 Jun 2020
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu M, Wu B, Wang WZ, Lee LM, Zhang SH, Kong LZ. Stroke in China: epidemiology, prevention, and management strategies. Lancet Neurol. 2007 May;6(5):456-64. doi: 10.1016/S1474-4422(07)70004-2.
PubMed 17434100Wu Z, Yao C, Zhao D, Wu G, Wang W, Liu J, Zeng Z, Wu Y. Sino-MONICA project: a collaborative study on trends and determinants in cardiovascular diseases in China, Part i: morbidity and mortality monitoring. Circulation. 2001 Jan 23;103(3):462-8. doi: 10.1161/01.cir.103.3.462.
PubMed 11157701Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3.
PubMed 22052510Smith EE, Fonarow GC, Reeves MJ, Cox M, Olson DM, Hernandez AF, Schwamm LH. Outcomes in mild or rapidly improving stroke not treated with intravenous recombinant tissue-type plasminogen activator: findings from Get With The Guidelines-Stroke. Stroke. 2011 Nov;42(11):3110-5. doi: 10.1161/STROKEAHA.111.613208. Epub 2011 Sep 8.
PubMed 21903949Barber PA, Zhang J, Demchuk AM, Hill MD, Buchan AM. Why are stroke patients excluded from TPA therapy? An analysis of patient eligibility. Neurology. 2001 Apr 24;56(8):1015-20. doi: 10.1212/wnl.56.8.1015.
PubMed 11320171Nedeltchev K, Schwegler B, Haefeli T, Brekenfeld C, Gralla J, Fischer U, Arnold M, Remonda L, Schroth G, Mattle HP. Outcome of stroke with mild or rapidly improving symptoms. Stroke. 2007 Sep;38(9):2531-5. doi: 10.1161/STROKEAHA.107.482554. Epub 2007 Aug 2.
PubMed 17673713Smith EE, Abdullah AR, Petkovska I, Rosenthal E, Koroshetz WJ, Schwamm LH. Poor outcomes in patients who do not receive intravenous tissue plasminogen activator because of mild or improving ischemic stroke. Stroke. 2005 Nov;36(11):2497-9. doi: 10.1161/01.STR.0000185798.78817.f3. Epub 2005 Oct 6.
PubMed 16210552Coutts SB, Dubuc V, Mandzia J, Kenney C, Demchuk AM, Smith EE, Subramaniam S, Goyal M, Patil S, Menon BK, Barber PA, Dowlatshahi D, Field T, Asdaghi N, Camden MC, Hill MD; TEMPO-1 Investigators. Tenecteplase-tissue-type plasminogen activator evaluation for minor ischemic stroke with proven occlusion. Stroke. 2015 Mar;46(3):769-74. doi: 10.1161/STROKEAHA.114.008504. Epub 2015 Feb 12.
PubMed 25677596Khatri P, Tayama D, Cohen G, Lindley RI, Wardlaw JM, Yeatts SD, Broderick JP, Sandercock P; PRISMS and IST-3 Collaborative Groups. Effect of Intravenous Recombinant Tissue-Type Plasminogen Activator in Patients With Mild Stroke in the Third International Stroke Trial-3: Post Hoc Analysis. Stroke. 2015 Aug;46(8):2325-7. doi: 10.1161/STROKEAHA.115.009951. Epub 2015 Jun 23.
PubMed 26106113National Institute of Neurological Disorders Stroke rt-PA Stroke Study Group. Recombinant tissue plasminogen activator for minor strokes: the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study experience. Ann Emerg Med. 2005 Sep;46(3):243-52. doi: 10.1016/j.annemergmed.2005.02.013.
PubMed 16126134Khatri P, Kleindorfer DO, Yeatts SD, Saver JL, Levine SR, Lyden PD, Moomaw CJ, Palesch YY, Jauch EC, Broderick JP. Strokes with minor symptoms: an exploratory analysis of the National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator trials. Stroke. 2010 Nov;41(11):2581-6. doi: 10.1161/STROKEAHA.110.593632. Epub 2010 Sep 2.
PubMed 20814000Tao Y, Gao Y, Zhao L, Xu Y, Jiang C, Liu K, Fang H, Pei L, Wang X, Zhang R, Wu J, Yang J, Han X, Guo H, Xue B, Li J, Liu Y, Gu H, Du K, Cheng X, Dong Q, Wang D, Buonanno FS, Ning M, Xu Y, Song B; TRUST Trial Investigators. Effect of intravenous urokinase vs best medicine treatment on functional outcome for patients with acute minor stroke (TRUST): a randomized controlled trial. BMC Med. 2025 Jan 6;23(1):6. doi: 10.1186/s12916-024-03820-2.
PubMed 39757192
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase ⅢB, Prospective, Randomized, Open Label, Blinded-endpoint, Multicenter Trial of the Efficacy and Safety of Urokinase Thrombolysis Comparing With Antiplatelet Agents for Patients With Minor Stroke.
- ClinicalTrials.gov ID
- NCT04420351
- Acronym / sponsor ID
- TRUST / 2017YFC1308202
- Conditions
- Minor Stroke
- Keywords
- Thrombolysis, Urokinase, Ischemic stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Shanghai 10th People's Hospital, General Hospital of Shenyang Military Region
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will enroll patients that have been diagnosed with minor stroke, which has occurred within the past 6 hours. TRUST is a prospective multicenter, randomized, blinded-endpoint study to evaluate the efficacy and safety of Urokinase Thrombolysis for patients with minor stroke.
Detailed description
China is currently faced with the heaviest stroke burden due to the tremendous population and susceptibility to cerebrovascular disease. As has been assessed, deaths caused by cerebrovascular disease are three times of cardiovascular disease. Within whole population with cerebrovascular disease, minor stoke have taken a significant part of the disease burden. Thus the population with minor stoke is one of the most important parts in efficient prevention of cerebrovascular disease. According to phase I and II data from national stoke registration in China, 35.25% to 42.23% cases were minor ischemic strokes. However, in clinical practice, the minor ischemic stroke patients are likely to be ignored and some might have poor prognosis. As has been demonstrated by a number of studies, up to one third of the acute non-disabling ischemic stroke without in-time thrombolysis may suffer from disabling or death at 90-day follow-up.
Several studies have demonstrated the potential benefits of thrombolysis compared usually with placebo, including the Third International Stroke Trail ( IST-3, rt-PA to placebo, patients within 3 hours after attack, with blood pressure lower than 185/110mmHg and NIHSS≤5)，National Institute of Neurological Disorders and Stroke rt-PA Stroke Study（ NINDS, rt-PA to placebo, patients with mild ischemic stroke recognized by 5 different definitions）.
Urokinase is a kind of non-selective plasminogen activator, urokinase acted as effective catalyzer in the transferring of both free and protein-binding plasminogen to plasmin, thus inducing thrombolysis. As one of the widely used medication for intravenous thrombolysis in China, urokinase has been suggested the the efficacy and safety for ischemic stroke. With easier availability and lower price, urokinase has provided a promising alternation to patients who need thrombolysis in China, especially in less developed areas. The Chinese guideline for diagnosis and treatment of acute ischemic stroke 2018 has recommended urokinase as an alternation in the treatment of acute ischemic stroke within 6-hour time window as well, if rt-PA is not available or affordable. However, randomized and multicenter clinical trial of urokinase thrombolysis for minor stroke is still vacant, which couldn't provide more persuasive evidence.
TRUST is a prospective multicenter, randomized, single-blind evaluation study to evaluate the efficacy and safety of Urokinase Thrombolysis for patients with minor stroke. The trail will enroll a total of 1002 minor stroke patients within a 6 hour time window with a NIHSS score ≤5 at the time of randomization. Randomization will be 1:1 to Urokinase Thrombolysis (experimental) or Antiplatelet agents (control). Patients will receive 1 million units urokinase dissolved by 100ml saline through intravenous infusion within 30min or oral antiplatelet agents. All patients will undergo CT or MRI before treatment and will undergo the second CT within 36 hours after treatment. Patients will be followed up at 36h, 7d and 90 days. The primary outcome measures including the proportion of patients with a modified Rankin Scale(mRS) of 0 or 1 at 90-day follow-up and the patients with symptomatic intracranial hemorrhage within 36 hours. Secondary outcome measures cover new vascular events, the Progress of MRS score, Neurological impairment, Daily function evaluations, Quality of life assessments, Overall mortality and Adverse events and severe adverse events within 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urokinase thrombolysis | Experimental | Drug: Urokinase thrombolysisThe patients of intervention group will receive 1 millions units urokinase dissolved by 100 saline through intravenous infusion within 30 minutes. |
| Antiplatelet treatment | Other | Drug: Aspirin;ClopidogrelThe control group will receive antiplatelet agents as decided by the physicians according to Chinese guideline for diagnosis and treatment of acute ischemic stroke 2018 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients: 18-80 years old
- The time from last seen well to treatment < 6 hours
- Minor stroke defined as a baseline NIHSS ≤5 at the time of randomization..
- First onset or pre-stroke mRS≤1
- Informed consent signed
Key exclusion criteria (31 listed)
- 1.Hyperdensity on CT suggesting intracranial hemorrhage
- 2.Large acute stroke >1/3 middle cerebral artery (MCA) territory visible on CT or MRI
- Intracranial tumor, arteriovenous malformation
- Coma or confirmed as severe stroke by clinical assessment (e.g. NIHSS ≥25) or proper imaging methods
- With seizure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urokinase thrombolysisAlso: UrokinaseThe patients of intervention group will receive 1 millions units urokinase dissolved by 100 saline through intravenous infusion within 30 minutes. | Drug | Urokinase thrombolysis |
| Aspirin;ClopidogrelAlso: Antiplatelet treatmentThe control group will receive antiplatelet agents as decided by the physicians according to Chinese guideline for diagnosis and treatment of acute ischemic stroke 2018. | Drug | Antiplatelet treatment |
Primary outcome
Proportion of patients with a modified Rankin Scale(mRS) of 0 or 1 at 90-day follow-up
Time frame: 90 Days
mRS has 0-6 points, the higher the worse outcome.
Proportion of patients with symptomatic intracranial hemorrhage within 36 hours
Time frame: 36 hours
Symptomatic intracranial haemorrhage within 36 hours
8 secondary outcomes
Proportion of patients with new vascular events
Time frame: 90 days
MRS score
Time frame: 90 days
The ratio of patients with MRS 0-1 during the last visit in two groups
Time frame: 90 days
Changes in National Institutes of Health Stroke Scale(NIHSS) score
Time frame: 90 days
Barthel index (BI) score
Time frame: 90 days
Quality of life assessments
Time frame: 90 days
Overall mortality
Time frame: 90 days
Adverse events and severe adverse events
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 17434100Liu M, Wu B, Wang WZ, Lee LM, Zhang SH, Kong LZ. Stroke in China: epidemiology, prevention, and management strategies. Lancet Neurol. 2007 May;6(5):456-64. doi: 10.1016/S1474-4422(07)70004-2.
- Background: PubMed 11157701Wu Z, Yao C, Zhao D, Wu G, Wang W, Liu J, Zeng Z, Wu Y. Sino-MONICA project: a collaborative study on trends and determinants in cardiovascular diseases in China, Part i: morbidity and mortality monitoring. Circulation. 2001 Jan 23;103(3):462-8. doi: 10.1161/01.cir.103.3.462.
- Background: PubMed 22052510Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011 Dec;42(12):3651-4. doi: 10.1161/STROKEAHA.111.635755. Epub 2011 Nov 3.
- Background: PubMed 21903949Smith EE, Fonarow GC, Reeves MJ, Cox M, Olson DM, Hernandez AF, Schwamm LH. Outcomes in mild or rapidly improving stroke not treated with intravenous recombinant tissue-type plasminogen activator: findings from Get With The Guidelines-Stroke. Stroke. 2011 Nov;42(11):3110-5. doi: 10.1161/STROKEAHA.111.613208. Epub 2011 Sep 8.
- Background: PubMed 11320171Barber PA, Zhang J, Demchuk AM, Hill MD, Buchan AM. Why are stroke patients excluded from TPA therapy? An analysis of patient eligibility. Neurology. 2001 Apr 24;56(8):1015-20. doi: 10.1212/wnl.56.8.1015.
- Background: PubMed 17673713Nedeltchev K, Schwegler B, Haefeli T, Brekenfeld C, Gralla J, Fischer U, Arnold M, Remonda L, Schroth G, Mattle HP. Outcome of stroke with mild or rapidly improving symptoms. Stroke. 2007 Sep;38(9):2531-5. doi: 10.1161/STROKEAHA.107.482554. Epub 2007 Aug 2.
- Background: PubMed 16210552Smith EE, Abdullah AR, Petkovska I, Rosenthal E, Koroshetz WJ, Schwamm LH. Poor outcomes in patients who do not receive intravenous tissue plasminogen activator because of mild or improving ischemic stroke. Stroke. 2005 Nov;36(11):2497-9. doi: 10.1161/01.STR.0000185798.78817.f3. Epub 2005 Oct 6.
- Background: PubMed 25677596Coutts SB, Dubuc V, Mandzia J, Kenney C, Demchuk AM, Smith EE, Subramaniam S, Goyal M, Patil S, Menon BK, Barber PA, Dowlatshahi D, Field T, Asdaghi N, Camden MC, Hill MD; TEMPO-1 Investigators. Tenecteplase-tissue-type plasminogen activator evaluation for minor ischemic stroke with proven occlusion. Stroke. 2015 Mar;46(3):769-74. doi: 10.1161/STROKEAHA.114.008504. Epub 2015 Feb 12.
- Background: PubMed 26106113Khatri P, Tayama D, Cohen G, Lindley RI, Wardlaw JM, Yeatts SD, Broderick JP, Sandercock P; PRISMS and IST-3 Collaborative Groups. Effect of Intravenous Recombinant Tissue-Type Plasminogen Activator in Patients With Mild Stroke in the Third International Stroke Trial-3: Post Hoc Analysis. Stroke. 2015 Aug;46(8):2325-7. doi: 10.1161/STROKEAHA.115.009951. Epub 2015 Jun 23.
- Background: PubMed 16126134National Institute of Neurological Disorders Stroke rt-PA Stroke Study Group. Recombinant tissue plasminogen activator for minor strokes: the National Institute of Neurological Disorders and Stroke rt-PA Stroke Study experience. Ann Emerg Med. 2005 Sep;46(3):243-52. doi: 10.1016/j.annemergmed.2005.02.013.
- Background: PubMed 20814000Khatri P, Kleindorfer DO, Yeatts SD, Saver JL, Levine SR, Lyden PD, Moomaw CJ, Palesch YY, Jauch EC, Broderick JP. Strokes with minor symptoms: an exploratory analysis of the National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator trials. Stroke. 2010 Nov;41(11):2581-6. doi: 10.1161/STROKEAHA.110.593632. Epub 2010 Sep 2.
- Derived from this study: PubMed 39757192Tao Y, Gao Y, Zhao L, Xu Y, Jiang C, Liu K, Fang H, Pei L, Wang X, Zhang R, Wu J, Yang J, Han X, Guo H, Xue B, Li J, Liu Y, Gu H, Du K, Cheng X, Dong Q, Wang D, Buonanno FS, Ning M, Xu Y, Song B; TRUST Trial Investigators. Effect of intravenous urokinase vs best medicine treatment on functional outcome for patients with acute minor stroke (TRUST): a randomized controlled trial. BMC Med. 2025 Jan 6;23(1):6. doi: 10.1186/s12916-024-03820-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Song, MD;PhD principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Urokinase thrombolysis and Aspirin;Clopidogrel in people with Minor Stroke, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a modified Rankin Scale(mRS) of 0 or 1 at 90-day follow-up (time frame: 90 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04420351, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.