Intravenous Alteplase ThrombolysisPhase 4GIANTNCT03772847
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial
A Phase 4 study testing ginkgolide in people with Intravenous Alteplase Thrombolysis and Neurological Improving, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Previous clinical studies have confirmed that revascularization or recanalization rate after intravenous thrombolysis is closely related to the formation of thrombus, which also results in poor neurological function after thrombolysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Alteplase Thrombolysis, Neurological Improving
- What is being tested?
- ginkgolide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,189 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2018to 31 Dec 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old, clinically diagnosed as acute ischemic stroke;
- in accordance with the indications for intravenous thrombolysis;
- The patient or family member signs an informed consent form.
Who cannot join
- Patients with transient ischemic attack;
- Imaging examination of patients with cerebral hemorrhage
- patients with cerebral arteritis
- ALT, AST ≥ 3 times the upper limit of normal value, Cr ≥ 1.5 times the upper limit of normal value
- There is a tendency to bleed, and severe bleeding has occurred within 3 months
- Patients with ginkgo drugs, alcohol, glycerol allergies or allergies
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- Patients with pregnancy plans, pregnancy and breastfeeding
- Patients who participated in other drug clinical studies in the past month
- Patients considered by the investigator to be unfit to participate in the clinical study (eg, mental, abnormal, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Previous clinical studies have confirmed that revascularization or recanalization rate after intravenous thrombolysis is closely related to the formation of thrombus, which also results in poor neurological function after thrombolysis. Platelet activating factor (PAF) strong platelet aggregation may be involved in thrombosis. Formation process. The main components of Ginkgolide injection (Ginkgo) are ginkgolide, ginkgolides A, ginkgolides B and ginkgolides C. Ginkgo biloba lactone can antagonize PAF and has strong anti-platelet aggregation. . Therefore, it can be speculated that ginkgolides injection combined with alteplase intravenous thrombolysis may improve the recanalization rate after thrombolysis and reduce the reocclusion rate.
In addition, clinical studies have also found that ginkgolide injection has a good auxiliary effect on hypertensive intracerebral hemorrhage, which can regulate inflammatory factors such as IL-6, TNF-α and high-sensitivity C-reactive protein (CRP) in patients. Recovery of neurological function in patients. It is well known that TNF-α, IL-β, IL-1, IL-6, IFN-γ, etc. are all inflammatory factors associated with reperfusion injury. Therefore, we speculate that ginkgolides injection may also regulate inflammatory factors associated with reperfusion injury, such as IL-6, TNF-α, thereby reducing reperfusion injury, thereby improving patient prognosis.
The aim of this study was to determine the clinical efficacy of ginkgolides injection combined with alteplase in the treatment of acute ischemic stroke, and to improve the prognosis of patients with thrombolysis.
- Being tested
- ginkgolide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ginkgolideDrug
ginkgolide plus alteplase
| Study group | Role | What they receive |
|---|---|---|
| ginkgolide group | Experimental | ginkgolide plus alteplase Receives: Drug: ginkgolide |
| control | No intervention | alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2
mRS 0-6, higher indicate worse outcome
Measured: 90 days
Secondary outcomes (3)
National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days
NIHSS 0-42, and higher indicate worse outcome
Measured: 14 days
recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up
Measured: 3 months
incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism）
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start31 Jul 2018
- Primary completion1 May 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous Alteplase ThrombolysisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,189 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dongyang People's Hospital, Haiyan People's Hospital, The Second Affiliated Hospital of Jiaxing University, Tongxiang Second People's Hospital, Tongxiang First People's Hospital, Changxing People's Hospital, The Central Hospital of Lishui City, The First People's Hospital of Huzhou, Taizhou First People's Hospital
- Responsible party
- Sponsor
- Investigators
- Ze Xin Chen, Study chair, 2nd affiliated hospital of Zhejiang University，School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772847
- Sponsor's protocol ID
- Yan 2018-015
- Acronym
- GIANT
- Status last verified
- Jul 2021
- First submitted
- 5 Sep 2018
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang X, Zhong W, Ma X, Zhang X, Chen H, Wang Z, Lou M. Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT). Front Pharmacol. 2021 Dec 3;12:792136. doi: 10.3389/fphar.2021.792136. eCollection 2021.
PubMed 34925044
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial
- ClinicalTrials.gov ID
- NCT03772847
- Acronym / sponsor ID
- GIANT / Yan 2018-015
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,189 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Dongyang People's Hospital, Haiyan People's Hospital, The Second Affiliated Hospital of Jiaxing University, Tongxiang Second People's Hospital, Tongxiang First People's Hospital, Changxing People's Hospital, The Central Hospital of Lishui City, The First People's Hospital of Huzhou, Taizhou First People's Hospital
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Dec 2018 (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.
Previous clinical studies have confirmed that revascularization or recanalization rate after intravenous thrombolysis is closely related to the formation of thrombus, which also results in poor neurological function after thrombolysis. Platelet activating factor (PAF) strong platelet aggregation may be involved in thrombosis. Formation process. The main components of Ginkgolide injection (Ginkgo) are ginkgolide, ginkgolides A, ginkgolides B and ginkgolides C. Ginkgo biloba lactone can antagonize PAF and has strong anti-platelet aggregation. . Therefore, it can be speculated that ginkgolides injection combined with alteplase intravenous thrombolysis may improve the recanalization rate after thrombolysis and reduce the reocclusion rate.
In addition, clinical studies have also found that ginkgolide injection has a good auxiliary effect on hypertensive intracerebral hemorrhage, which can regulate inflammatory factors such as IL-6, TNF-α and high-sensitivity C-reactive protein (CRP) in patients. Recovery of neurological function in patients. It is well known that TNF-α, IL-β, IL-1, IL-6, IFN-γ, etc. are all inflammatory factors associated with reperfusion injury. Therefore, we speculate that ginkgolides injection may also regulate inflammatory factors associated with reperfusion injury, such as IL-6, TNF-α, thereby reducing reperfusion injury, thereby improving patient prognosis.
The aim of this study was to determine the clinical efficacy of ginkgolides injection combined with alteplase in the treatment of acute ischemic stroke, and to improve the prognosis of patients with thrombolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ginkgolide group | Experimental | Drug: ginkgolideginkgolide plus alteplase |
| control | No intervention | –alteplase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years old, clinically diagnosed as acute ischemic stroke;
- in accordance with the indications for intravenous thrombolysis;
- The patient or family member signs an informed consent form.
Key exclusion criteria (9 listed)
- Patients with transient ischemic attack;
- Imaging examination of patients with cerebral hemorrhage
- patients with cerebral arteritis
- ALT, AST ≥ 3 times the upper limit of normal value, Cr ≥ 1.5 times the upper limit of normal value
- There is a tendency to bleed, and severe bleeding has occurred within 3 months
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 |
|---|---|---|
| ginkgolideginkgolide plus alteplase | Drug | ginkgolide group |
Primary outcome
proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2
Time frame: 90 days
mRS 0-6, higher indicate worse outcome
3 secondary outcomes
National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days
Time frame: 14 days
recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up
Time frame: 3 months
incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism）
Time frame: 1 year
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 6 May 2022.
- Derived from this study: PubMed 34925044Zhang X, Zhong W, Ma X, Zhang X, Chen H, Wang Z, Lou M. Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT). Front Pharmacol. 2021 Dec 3;12:792136. doi: 10.3389/fphar.2021.792136. eCollection 2021.
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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.
Ze Xin Chen study chair
2nd affiliated hospital of Zhejiang University，School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ginkgolide in people with Intravenous Alteplase Thrombolysis and Neurological Improving, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 9 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 6 May 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 90-day modified Rankin Scale (mRS) score below 2 (time frame: 90 days). 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 NCT03772847, which also lists 1 linked publication.
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 6 May 2022.