Acute Ischemic StrokeNCT07269288
The Correlation and Mechanistic Study of GGCX Gene With Prognosis in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Peking University Aerospace Center Hospital at 1 site in China.
Trial summary
This observational study aims to investigate the impact of GGCX gene mutations and GGCX levels on stroke prognosis in patients with ischemic stroke, as well as their correlation. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Usually, all enrolled patients with acute ischemic stroke will receive routine medication and/or surgical treatment according to clinical diagnosis and treatment protocols.
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2026to 28 Feb 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will be conducted in six hospitals (centers) across the country, namely Xi'an Jiaotong University First Affiliated Hospital, Shandong Weifang Second People's Hospital, Shandong Linshu People's Hospital, Hunan Second People's Hospital (Hunan Brain Hospital), and Nantong First People's Hospital.
Who may be able to join
- Inclusion Criteria for Acute Ischemic Stroke Patients:
- Aged between 18 and 85 years.
- Diagnosed with ischemic stroke (in accordance with the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023," including TOAST etiological/pathogenic subtypes: large-artery atherosclerosis (LAA), cardioembolism (CE), small-artery occlusion (SAO), stroke of other determined etiology (SOE), and stroke of undetermined etiology (SUE)).
- Acute onset, with symptoms occurring within 72 hours and being the first episode.
- Voluntary participation with signed informed consent.
- Inclusion Criteria for Healthy Controls: 1) Healthy control population matched for age, gender, and risk factors (including personal and family history).
Who cannot join
- Exclusion Criteria for Healthy Controls:
- Patients with cerebrovascular diseases occurring within 72 hours.
- Pregnant or lactating patients.
- Exclusion Criteria for Acute Ischemic Stroke Patients:
- Other types of stroke, including hemorrhagic stroke, mixed stroke, and tumor-related stroke patients.
- Patients with coagulation disorders or other hematologic diseases.
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- Patients with severe cardiovascular, pulmonary, or hepatic diseases.
- Renal dysfunction.
- Cancer patients.
- Patients with active gastric ulcers or gastric bleeding.
- Pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study Protocol on the Correlation and Mechanistic Study of GGCX Gene With Prognosis in Acute Ischemic Stroke
This observational study aims to investigate the impact of GGCX gene mutations and GGCX levels on stroke prognosis in patients with ischemic stroke, as well as their correlation. The main issues are:
What is the relationship and potential mechanism between GGCX gene mutations and their expression levels and the composite prognosis of recurrence, death, and bleeding events in patients with ischemic stroke? Collect blood samples from enrolled ischemic stroke patients for genetic testing, and conduct follow-up visits at 3, 6, and 12 months after discharge to evaluate clinical prognosis outcomes. This will answer questions about the relationship and mechanism between GGCX gene and patient prognosis.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Usually, all enrolled patients with acute ischemic stroke will receive routine medication and/or surgical treatment according to clinical diagnosis and treatment protocols.
- Keywords
- Stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usually, all enrolled patients with acute ischemic stroke will receive routine medication and/or surgical treatment according to clinical diagnosis and treatment protocols.Combination product
The conventional drug therapy includes anticoagulant, antiplatelet, antihypertensive and other drugs. The surgical therapy includes AIS intravenous thrombolysis or endovascular therapy.
| Study group | Role | What they receive |
|---|---|---|
| Acute Ischemic Stroke Group | These subjects were acute ischemic stroke patients who had been followed up for 3-12 months after discharge. Receives: Combination Product: Usually, all enrolled patients with acute ischemic stroke will receive routine medication and/or surgical treatment according to clinical diagnosis and treatment protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the recurrence, death, and bleeding events of stroke in the research subjects
Including recurrent ischemic stroke events; Death events include hemorrhagic death, vascular death, and acute myocardial infarction events; Intracranial or other bleeding events (refer to the International Classification of Bleeding Events ICD-10 code).
Measured: Follow up will be conducted at 3 months, 6 months, and 12 months after the patient's discharge, and the main outcome events mentioned above will be evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start25 Jan 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Zhang, Aerospace Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269288
- Sponsor's protocol ID
- 2025017
- Other IDs
- 2024PSPT0905100
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will decide whether to share based on laws and regulations and the management measures of the Clinical Trial Ethics Committee.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol on the Correlation and Mechanistic Study of GGCX Gene With Prognosis in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07269288
- Acronym / sponsor ID
- 2025017
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Peking University Aerospace Center HospitalUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 8 Dec 2025 (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 observational study aims to investigate the impact of GGCX gene mutations and GGCX levels on stroke prognosis in patients with ischemic stroke, as well as their correlation. The main issues are:
What is the relationship and potential mechanism between GGCX gene mutations and their expression levels and the composite prognosis of recurrence, death, and bleeding events in patients with ischemic stroke? Collect blood samples from enrolled ischemic stroke patients for genetic testing, and conduct follow-up visits at 3, 6, and 12 months after discharge to evaluate clinical prognosis outcomes. This will answer questions about the relationship and mechanism between GGCX gene and patient prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Ischemic Stroke Group | – | Combination Product: Usually, all enrolled patients with acute ischemic stroke will receive routine medication and/or surgical treatment according to clinical diagnosis and treatment protocols.These subjects were acute ischemic stroke patients who had been followed up for 3-12 months after discharge. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in six hospitals (centers) across the country, namely Xi'an Jiaotong University First Affiliated Hospital, Shandong Weifang Second People's Hospital, Shandong Linshu People's Hospital, Hunan Second People's Hospital (Hunan Brain Hospital), and Nantong First People's Hospital.
Key inclusion criteria (6 listed)
Key exclusion criteria (11 listed)
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 |
|---|---|---|
| Usually, all enrolled patients with acute ischemic stroke will receive routine medication and/or surgical treatment according to clinical diagnosis and treatment protocols.The conventional drug therapy includes anticoagulant, antiplatelet, antihypertensive and other drugs. The surgical therapy includes AIS intravenous thrombolysis or endovascular therapy. | Combination product | Acute Ischemic Stroke Group |
Primary outcome
Evaluate the recurrence, death, and bleeding events of stroke in the research subjects
Time frame: Follow up will be conducted at 3 months, 6 months, and 12 months after the patient's discharge, and the main outcome events mentioned above will be evaluated.
Including recurrent ischemic stroke events; Death events include hemorrhagic death, vascular death, and acute myocardial infarction events; Intracranial or other bleeding events (refer to the International Classification of Bleeding Events ICD-10 code).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided. IPD will decide whether to share based on laws and regulations and the management measures of the Clinical Trial Ethics Committee.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Peking University Aerospace Center 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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 8 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Zhang, PhD (8618120175562, xzhangccmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the recurrence, death, and bleeding events of stroke in the research subjects (time frame: Follow up will be conducted at 3 months, 6 months, and 12 months after the patient's discharge, and the main outcome events mentioned above will be evaluated.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2025.