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

Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03153878
• Other study ID #: 2016YFC1300803
• Status: Not yet recruiting
• Phase: N/A
• First received: May 11, 2017
• Last updated: May 11, 2017
• Start date: June 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2017
• Source: West China Hospital
• Contact: Zhiyong Liu, M.D, Ph.D
• Phone: +8613658021726
• Email: doctor_lzy[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 disease. The investigators aim to use research data to create a China national database of UIA

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Cerebrovascular Disorders
• Coronary Artery Disease
• Heart Diseases
• Intracranial Aneurysm
• Ischemia
• Ischemic Cerebrovascular Disease
• Ischemic Heart Disease
• Myocardial Ischemia
• Natural History

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Liu Zhiyong	Xuanwu Hospital, Beijing

References & Publications (3)

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. Erratum in: N Engl J Med 1999 Mar 4;340(9):744. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneurysm rupture	Aneurysm rupture	Up to 4 years or time of aneurysm repair surgery
Primary	Morphological changes of aneurysms	maximum diameter increase = 1mm or appearance of a daughter sac	Up to 4 years or time of aneurysm repair surgery
Secondary	Acute myocardial infarction	Acute myocardial infarction	Up to 4 years]
Secondary	New onset ischemic stroke	New onset ischemic stroke	Up to 4 years]