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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | |
Unique ID issued by UMIN | C000000172 |
Receipt No. | R000000027 |
Scientific Title | ANTI-PLATELET THERAPY FOR COIL EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSMS |
Date of disclosure of the study information | 2005/09/12 |
Last modified on | 2005/09/12 |
Basic information | ||
Public title | ANTI-PLATELET THERAPY FOR COIL EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSMS | |
Acronym | Japan ACE (Antiplatelet therapy for Coil Embolization) Trial | |
Scientific Title | ANTI-PLATELET THERAPY FOR COIL EMBOLIZATION OF UNRUPTURED CEREBRAL ANEURYSMS | |
Scientific Title:Acronym | Japan ACE (Antiplatelet therapy for Coil Embolization) Trial | |
Region |
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Condition | ||
Condition | Unruptured cerebral aneurysms | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The randomized clinical trial evaluating the effects of antiplatelet therapy for prevention of thromboembolic complications among patients undergoing endovascular treatments for unruptured intracranial aneurysms |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | All ischemic events or severe disability (including death) by another cause within a month |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | aspirin | |
Interventions/Control_2 | no prescription | |
Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Modified Rankin Scale 0~2, 2. Aneurysms larger than 5mm in maximum diameter treated by simple tachnique, 3. First treatment case | |||
Key exclusion criteria | 1. Past history of cerebral infarction, ICH and SAH, 2. Patients already prescribed, antiplatelets and anticoagulants, 3. Patients with atherosclerotic diseases, 4. Patients with AVM, 5. Hemorrhagic tendency, 6. Aspirin allergy | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cardiovascular Center | ||||||
Division name | Neurosurgery | ||||||
Zip code | |||||||
Address | 5-7-1 Fujisirodai Suita, Osaka 565-8565 JAPAN | ||||||
TEL | 06-6833-5012 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | National Cardiovascular Center | ||||||
Division name | Neurosurgery | ||||||
Zip code | |||||||
Address | 5-7-1 Fujisirodai Suita, Osaka 565-8565 JAPAN | ||||||
TEL | 06-6833-5012 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | National Cardiovascular Center |
Institute | |
Department |
Funding Source | |
Organization | Research grant from the Japanese Ministry of Health, Labor, and Welfare |
Organization | |
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Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000027 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |