Spontaneous Intracerebral HemorrhageNCT04820972
Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
A study testing Antiplatelet Agents in people with Spontaneous Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective, open-label, endpoint-blind, randomized controlled study.Patients receiving surgical treatment for SICH were divided into groups using the random machine method. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spontaneous Intracerebral Hemorrhage
- What is being tested?
- Antiplatelet Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 May 2023
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old.
- nontraumatic spontaneous intracerebral hemorrhage.
- postoperative patients with high risk of MACCPE:(1)previous history of cerebral infarction or TIA. (2)previous history of coronary heart disease or myocardial infarction.(3) use ASCVD Risk Estimator Plus（http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/） to assess the risk of ischemic events for patients with no previous history of cerebral infarction, TIA, or coronary heart diseases or myocardial infarction,10 years risk>10% is defined as a high risk of cardiovascular ischemic events(4)The Caprini Risk Scale is used to assess the risk of venous thrombosis in the lower extremities.Score>2 is defined as a high risk of venous thrombosis.
- patients who received neurosurgical procedures to remove the hematoma, including craniotomy, endoscopic hematoma removal and hematoma aspiration.
- patients who signed informed consent.
- no history of allergy to salicylic acid preparation.
- patients who complete the preintervention assessment and meet the fellow criteria:(1)postoperative head CT showed no new infarction or hemorrhage(2)postoperative venous ultrasound of the lower extremity did not reveal deep vein thrombosis.(3)postoperative electrocardiogram and myocardial enzyme examination did not show acute myocardial ischemia or myocardial infarction.
Who cannot join
- there are structural cerebrovascular lesions (such as intracranial aneurysms, cerebrovascular malformations, etc.) or tumors in the area of bleeding or the bleeding is suspected to be related to these lesions.
- ischemic stroke with hemorrhagic conversion.
- secondary bleeding due to venous embolism.
- the malignant tumor is expected to have a survival of no more than 3 months.
- take antithrombotic agents((Vitamin K antagonists (warfarin) new anticoagulants(Dabigatun Rivaroxaban))) in addition to antiplatelet agents.
- previous history of thrombocytopenia or coagulation disorders.
- previous history of atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Affiliated Beijing Tiantan Hospital
Beijing, Beijing Municipality
About this study
This study is a multicenter, prospective, open-label, endpoint-blind, randomized controlled study.Patients receiving surgical treatment for SICH were divided into groups using the random machine method. In addition to conventional treatment for spontaneous intracerebral hemorrhage, patients in the group of early initiation of antiplatelet therapy were given conventional dose of aspirin (100mg, qd) antiplatelet therapy starting from the 3rd day after surgery.An independent group of investigators evaluated cardiac, cerebral and peripheral vascular events and bleeding events at four different time points.To evaluate the benefits and safety of early postoperative initiation of antiplatelet therapy in patients with spontaneous intracerebral hemorrhage.
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Being tested
- Antiplatelet Agents
- Keywords
- antiplatelet treatment, spontaneous intracerebral hemorrhage, early-start, neurosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiplatelet AgentsDrug
using antiplatelet agents in 3 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| E-STAR group | Experimental | Not described Receives: Drug: Antiplatelet Agents |
| traditional group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of intracranial hemorrhage
Measured: 7 days after surgery
rate of intracranial hemorrhage
Measured: 14 days after surgery
rate of intracranial hemorrhage
Measured: 30 days after surgery
rate of intracranial hemorrhage
Measured: 90 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Measured: 7 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Measured: 14 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Measured: 30 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 May 2021
- Primary completion1 Feb 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Fujian Medical University, Second Xiangya Hospital of Central South University, First Affiliated Hospital of Harbin Medical University, Gangzhou Red Cross Hospital ，Jinan University, Beijing Chao Yang Hospital, RenJi Hospital, Sichuan Academy of Medical Sciences, Chongqing General Hospital, Binzhou Medical University, Fujian Medical University Union Hospital, Shanxi Provincial People's Hospital, Beijing Friendship Hospital, Qilu Hospital of Shandong University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Principal investigator, Wang Shuo, Beijing Tiantan Hospital
- Investigators
- Shuo Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820972
- Sponsor's protocol ID
- HX-A-007（2021）
- Status last verified
- Jun 2023
- First submitted
- 24 Mar 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Q, Mo S, Wu J, Tong X, Wang K, Chen X, Chen S, Guo S, Li X, Li M, Peng L, Sun X, Wang Y, Sun J, Pu J, Zheng K, Zhang J, Liu Y, Yang Y, Wen Z, Nie X, Feng Y, Lan C, Tang H, Wang N, Li J, Miao Z, Lu X, Ning B, Zhao B, Kang D, Chen X, Zhang Y, Zhang Y, Wang A, Zhu C, Araki Y, Uda K, Yoshimura S, Uchida K, Morimoto T, Yoshioka H, Hasan D, Du R, Levitt MR, Cao Y, Wang S, Zhao J; E-start collaborators. Safety and efficacy of early versus delayed acetylsalicylic acid after surgery for spontaneous intracerebral haemorrhage in China (E-start): a prospective, multicentre, open-label, blinded-endpoint, randomised trial. Lancet Neurol. 2024 Dec;23(12):1195-1204. doi: 10.1016/S1474-4422(24)00424-1.
PubMed 39577920Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
PubMed 36700520Wang K, Mo S, Liu Q, Pu J, Huang X, Kang D, Lin F, Zou D, Sun X, Ren J, Tong X, Li J, Salman RA, Wang N, Guo S, Liu Y, Zhang Y, Li X, Wu J, Wang S. Early-start antiplatelet therapy after operation in patients with spontaneous intracerebral hemorrhage and high risk of ischemic events (E-start): Protocol for a multi-centered, prospective, open-label, blinded endpoint randomized controlled trial. Front Aging Neurosci. 2022 Nov 23;14:1020224. doi: 10.3389/fnagi.2022.1020224. eCollection 2022.
PubMed 36506468
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early-Start Antiplatelet Treatment After Neurosurgery in Patients With Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT04820972
- Acronym / sponsor ID
- HX-A-007（2021）
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Keywords
- antiplatelet treatment, spontaneous intracerebral hemorrhage, early-start, neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Fujian Medical University, Second Xiangya Hospital of Central South University, First Affiliated Hospital of Harbin Medical University, Gangzhou Red Cross Hospital ，Jinan University, Beijing Chao Yang Hospital, RenJi Hospital, Sichuan Academy of Medical Sciences, Chongqing General Hospital, Binzhou Medical University, Fujian Medical University Union Hospital, Shanxi Provincial People's Hospital, Beijing Friendship Hospital, Qilu Hospital of Shandong University, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 29 Mar 2021 (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 study is a multicenter, prospective, open-label, endpoint-blind, randomized controlled study.Patients receiving surgical treatment for SICH were divided into groups using the random machine method. In addition to conventional treatment for spontaneous intracerebral hemorrhage, patients in the group of early initiation of antiplatelet therapy were given conventional dose of aspirin (100mg, qd) antiplatelet therapy starting from the 3rd day after surgery.An independent group of investigators evaluated cardiac, cerebral and peripheral vascular events and bleeding events at four different time points.To evaluate the benefits and safety of early postoperative initiation of antiplatelet therapy in patients with spontaneous intracerebral hemorrhage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-STAR group | Experimental | Drug: Antiplatelet Agents |
| traditional group | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-70 years old.
- nontraumatic spontaneous intracerebral hemorrhage.
- postoperative patients with high risk of MACCPE:(1)previous history of cerebral infarction or TIA. (2)previous history of coronary heart disease or myocardial infarction.(3) use ASCVD Risk Estimator Plus（http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/） to assess the risk of ischemic events for patients with no previous history of cerebral infarction, TIA, or coronary heart diseases or myocardial infarction,10 years risk>10% is defined as a high risk of cardiovascular ischemic events(4)The Caprini Risk Scale is used to assess the risk of venous thrombosis in the lower extremities.Score>2 is defined as a high risk of venous thrombosis.
- patients who received neurosurgical procedures to remove the hematoma, including craniotomy, endoscopic hematoma removal and hematoma aspiration.
- patients who signed informed consent.
Key exclusion criteria (7 listed)
- there are structural cerebrovascular lesions (such as intracranial aneurysms, cerebrovascular malformations, etc.) or tumors in the area of bleeding or the bleeding is suspected to be related to these lesions.
- ischemic stroke with hemorrhagic conversion.
- secondary bleeding due to venous embolism.
- the malignant tumor is expected to have a survival of no more than 3 months.
- take antithrombotic agents((Vitamin K antagonists (warfarin) new anticoagulants(Dabigatun Rivaroxaban))) in addition to antiplatelet agents.
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 |
|---|---|---|
| Antiplatelet Agentsusing antiplatelet agents in 3 days after surgery | Drug | E-STAR group |
Primary outcome
rate of intracranial hemorrhage
Time frame: 7 days after surgery
rate of intracranial hemorrhage
Time frame: 14 days after surgery
rate of intracranial hemorrhage
Time frame: 30 days after surgery
rate of intracranial hemorrhage
Time frame: 90 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Time frame: 7 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Time frame: 14 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Time frame: 30 days after surgery
rate of major adverse cardiac/cerebrovascular and peripheral vessel events
Time frame: 90 days after surgery
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 3 Apr 2025.
- Derived from this study: PubMed 39577920Liu Q, Mo S, Wu J, Tong X, Wang K, Chen X, Chen S, Guo S, Li X, Li M, Peng L, Sun X, Wang Y, Sun J, Pu J, Zheng K, Zhang J, Liu Y, Yang Y, Wen Z, Nie X, Feng Y, Lan C, Tang H, Wang N, Li J, Miao Z, Lu X, Ning B, Zhao B, Kang D, Chen X, Zhang Y, Zhang Y, Wang A, Zhu C, Araki Y, Uda K, Yoshimura S, Uchida K, Morimoto T, Yoshioka H, Hasan D, Du R, Levitt MR, Cao Y, Wang S, Zhao J; E-start collaborators. Safety and efficacy of early versus delayed acetylsalicylic acid after surgery for spontaneous intracerebral haemorrhage in China (E-start): a prospective, multicentre, open-label, blinded-endpoint, randomised trial. Lancet Neurol. 2024 Dec;23(12):1195-1204. doi: 10.1016/S1474-4422(24)00424-1.
- Derived from this study: PubMed 36700520Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.
- Derived from this study: PubMed 36506468Wang K, Mo S, Liu Q, Pu J, Huang X, Kang D, Lin F, Zou D, Sun X, Ren J, Tong X, Li J, Salman RA, Wang N, Guo S, Liu Y, Zhang Y, Li X, Wu J, Wang S. Early-start antiplatelet therapy after operation in patients with spontaneous intracerebral hemorrhage and high risk of ischemic events (E-start): Protocol for a multi-centered, prospective, open-label, blinded endpoint randomized controlled trial. Front Aging Neurosci. 2022 Nov 23;14:1020224. doi: 10.3389/fnagi.2022.1020224. eCollection 2022.
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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.
Shuo Wang, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiplatelet Agents in people with Spontaneous Intracerebral Hemorrhage, run by Beijing Tiantan Hospital 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 7 inclusion and 7 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 3 Apr 2025. 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.
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?
rate of intracranial hemorrhage (time frame: 7 days after surgery). The study lists 8 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 NCT04820972, which also lists 3 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 3 Apr 2025.