Intracranial AneurysmNCT03153878
The Prospective Cohort Study on the Benefit-risk of Antithrombotic or Anticoagulant Therapy in Patients With Unruptured Intracranial Aneurysms Associated With Ischemic Heart Disease or Ischemic Cerebrovascular Disease
An observational study of Intracranial Aneurysm and Natural History, run by Liu Zhiyong.
Trial summary
This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Intracranial Aneurysm, Natural History, Ischemic Heart Disease
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 31 Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease,who accept antithrombotic or anticoagulant therapy
Who may be able to join
- Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA);
- Patient with premorbid mRS of 3 or less;
- Patient older than 14years;
- Patient consenting to participate to the study;
- Patients with a definite history of ischemic heart disease or ischemic stroke who accept antithrombotic or anticoagulant therapy for secondary pevention
Who cannot join
- Subarachnoid hemorrhage with unknown causes;
- Page 4 of 4 [DRAFT] - 2. Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas; 3. Patient with malignant tumor; 4. Target aneurysm is fusiform, traumatic, mycotic, or dissecting related; 5. Inability to obtain informed consent; 6. Patients with a life expectancy less than 1 year; 7. Participating in the other clinical studies of intracranial aneurysm; 8. Refusal of follow-up
Trial locations and contacts
No sites are listed yet.
About this study
This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. The investigators aim to use research data to create a China national database of UIA
Read the detailed description
This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. The investigators aim to use research data to create a China national database of UIA. This study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China.
During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year. Research data will represent the real natural course of UIA in China. For this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made
- Conditions
- Intracranial Aneurysm, Natural History, Ischemic Heart Disease, Ischemic Cerebrovascular Disease
- Keywords
- Unruptured Intracranial Aneurysm, Benefit-risk, Ischemic heart disease, Ischemic cerebrovascular disease, Antithrombotic, Anticoagulant, People's Republic of China, Multicenter Studies
- Medical subject headings
- Intracranial Aneurysm, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm rupture
Aneurysm rupture
Measured: Up to 4 years or time of aneurysm repair surgery
Morphological changes of aneurysms
maximum diameter increase ≥ 1mm or appearance of a daughter sac
Measured: Up to 4 years or time of aneurysm repair surgery
Secondary outcomes (2)
Acute myocardial infarction
Acute myocardial infarction
Measured: Up to 4 years]
New onset ischemic stroke
New onset ischemic stroke
Measured: Up to 4 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
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 Intracranial AneurysmStudies 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
- 1,800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Liu Zhiyong
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor-investigator, Liu Zhiyong, West China Hospital
- Investigators
- Min He, M.D., Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153878
- Sponsor's protocol ID
- 2016YFC1300803
- Status last verified
- May 2017
- First submitted
- 11 May 2017
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: share the original data 5 years after the study completion
Publications
International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med. 1998 Dec 10;339(24):1725-33. doi: 10.1056/NEJM199812103392401.
PubMed 9867550Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
PubMed 12867109UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
PubMed 22738097
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective Cohort Study on the Benefit-risk of Antithrombotic or Anticoagulant Therapy in Patients With Unruptured Intracranial Aneurysms Associated With Ischemic Heart Disease or Ischemic Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT03153878
- Acronym / sponsor ID
- 2016YFC1300803
- Conditions
- Intracranial Aneurysm, Natural History, Ischemic Heart Disease, Ischemic Cerebrovascular Disease
- Keywords
- Unruptured Intracranial Aneurysm, Benefit-risk, Ischemic heart disease, Ischemic cerebrovascular disease, Antithrombotic, Anticoagulant, People's Republic of China, Multicenter Studies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Liu ZhiyongUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 May 2017 (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 is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. The investigators aim to use research data to create a China national database of UIA
Detailed description
This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. The investigators aim to use research data to create a China national database of UIA. This study is supported by a research grant from the Ministry of Science and Technology of the People's Republic of China. The investigators will collaborate with the other 19 medical centers which locate in the different districts of China.
During the study period, all the patients included in this study will observe and treat in the collaborating medical centers. Included patients will be followed-up for at least 1year. Research data will represent the real natural course of UIA in China. For this study, the investigators consulted and hired professional experts about data collection, data and methodology. An intact systematic project steering committee, including Data Monitoring Committee, Data Management Committee, Project Academic Committee, Executive Group, Project Manager, Project Statistician, and Technical Support Center has been built up. Scientific regulations have also been made
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease,who accept antithrombotic or anticoagulant therapy
Key inclusion criteria (5 listed)
- Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA);
- Patient with premorbid mRS of 3 or less;
- Patient older than 14years;
- Patient consenting to participate to the study;
- Patients with a definite history of ischemic heart disease or ischemic stroke who accept antithrombotic or anticoagulant therapy for secondary pevention
Key exclusion criteria (2 listed)
- Subarachnoid hemorrhage with unknown causes;
- Page 4 of 4 [DRAFT] - 2. Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas; 3. Patient with malignant tumor; 4. Target aneurysm is fusiform, traumatic, mycotic, or dissecting related; 5. Inability to obtain informed consent; 6. Patients with a life expectancy less than 1 year; 7. Participating in the other clinical studies of intracranial aneurysm; 8. Refusal of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aneurysm rupture
Time frame: Up to 4 years or time of aneurysm repair surgery
Aneurysm rupture
Morphological changes of aneurysms
Time frame: Up to 4 years or time of aneurysm repair surgery
maximum diameter increase ≥ 1mm or appearance of a daughter sac
2 secondary outcomes
Acute myocardial infarction
Time frame: Up to 4 years]
New onset ischemic stroke
Time frame: Up to 4 years]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Background: PubMed 9867550International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med. 1998 Dec 10;339(24):1725-33. doi: 10.1056/NEJM199812103392401.
- Background: PubMed 12867109Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
- Background: PubMed 22738097UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
- Individual participant dataSharing planned: No. share the original data 5 years after the study completion
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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.
Min He, M.D. study chair
West China Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Natural History, run by Liu Zhiyong.
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 2 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: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyong Liu, M.D, Ph.D (+8613658021726, doctor_lzy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm rupture (time frame: Up to 4 years or time of aneurysm repair surgery). 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 NCT03153878, 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 15 May 2017.