Clinical trial NCT03153878: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
First posted: 2017-05-15
Enrollment: 1800
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease,who accept antithrombotic or anticoagulant therapy

Brief 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 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

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA);
2. Patient with premorbid mRS of 3 or less;
3. Patient older than 14years;
4. Patient consenting to participate to the study;
5. Patients with a definite history of ischemic heart disease or ischemic stroke who accept antithrombotic or anticoagulant therapy for secondary pevention

Exclusion Criteria:

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

Primary outcomes:
measure: Aneurysm rupture
timeFrame: Up to 4 years or time of aneurysm repair surgery
measure: Morphological changes of aneurysms
timeFrame: Up to 4 years or time of aneurysm repair surgery
Secondary outcomes:
measure: Acute myocardial infarction
timeFrame: Up to 4 years]
measure: New onset ischemic stroke
timeFrame: Up to 4 years]
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Min He, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: Wiebers 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.
citation: UCAS 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.