ISRCTN21157803进行中（未招募）4 期
Preventing stroke, premature death and cognitive decline in a broader community of patients with atrial fibrillation using healthcare data for pragmatic research: A randomised controlled trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 19/06/2023:
- •1. Diagnosis of AF (previous, current or chronic)
- •2. Age at enrolment >=55 years to <=73 years
- •Previous inclusion criteria:
- •1. Diagnosis of AF (previous, current or chronic)
- •2. Age at enrolment >=60 years to <=73 years
排除标准
- •Current exclusion criteria as of 01/11/2022:
- •Participant exclusion criteria based on coding in the Primary Care record:
- •1. Prior documented stroke, transient ischaemic attack or systemic thromboembolism.
- •2. Combination of multiple known risk factors for stroke where oral anticoagulation would ordinarily be started, including: Heart failure; Hypertension; Age 65 years or older; Diabetes mellitus; Previous myocardial infarction, peripheral artery disease or aortic plaque; and/or Female gender.
- •3. Any prior history of intracranial bleeding.
- •4. Prior major bleeding requiring hospitalisation in the last 3 years.
- •5. Condition that poses a significant risk for bleeding (within 12 months) including gastrointestinal ulceration, brain/spinal/ophthalmic injury or surgery, arteriovenous malformations or vascular aneurysms, major intraspinal or intracerebral vascular abnormalities, hepatic disease associated with coagulopathy, known or suspected oesophageal varices, and cancers with high bleeding risk.
- •6. Estimated glomerular filtration rate <30 mL/min/1.73m² measured within the last 12 months.
- •7. Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole).
- •8. Documented diagnosis of dementia.
- •9. Hypersensitivity or known intolerance to direct oral anticoagulants.
- •Participant exclusion criteria based on review by Primary Care staff:
- •1. Currently receiving an anticoagulant.
- •2. Any clinical indication for anticoagulation.
- •3. Active clinically-significant bleeding.
- •4. Life expectancy estimated <2 years.
- •5. Participant unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records.
- •6. Currently participating in another clinical trial.
- •7. Women of childbearing potential.
- •Previous exclusion criteria as of 21/09/2021:
- •1. Existing use of an anticoagulant.
- •2. Another clinical indication for anticoagulation.
- •3. Hypersensitivity or known intolerance to direct oral anticoagulants.
- •4. Prior documented stroke, transient ischaemic attack or thromboembolism.
- •5. Two or more CHA2DS2-VASc one-point risk factors indicating a risk of stroke or thromboembolism: Heart failure, Hypertension; Age 65 years or older; Diabetes mellitus; Previous myocardial infarction, peripheral artery disease or aortic plaque; and/or Female gender (if in the presence of other risk factors).
- •6. Active clinically-significant bleeding.
- •7. Prior major bleeding, defined as any intracranial bleed, or bleeding that resulted in a drop in haemoglobin =2g/dL, required hospitalisation or transfusion.
- •8. Condition that poses a significant risk for bleeding (within 12 months) including gastrointestinal ulceration, brain/spinal/ophthalmic injury or surgery, arteriovenous malformations or vascular aneurysms, major intraspinal or intracerebral vascular abnormalities, hepatic disease associated with coagulopathy, known or suspected oesophageal varices, and cancer with high bleeding risk.
- •9. Estimated glomerular filtration rate <30 mL/min/1.73m2 measured within the last 12 months.
- •10. Patients receiving systemic treatment with azole-antimycotics within the last 3 months (ketoconazole, itraconazole, voriconazole and posaconazole).
- •11. Current diagnosis of dementia.
- •12. Life expectancy <2 years.
- •13. Unable or unwilling to provide informed consent for access and linkage of past and future electronic healthcare records.
- •14. Currently participating in another c
研究者
相似试验
进行中（未招募）
不适用
Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack.The PERFORM Study.An international, randomised, double-blind, two parallel group study comparing terutroban 30 mg o.d. versus aspirin 100 mg o.d. administered orally for a 3-year mean duration (event driven trial). - PERFORMIschaemic stroke or transient ischaemic attackMedDRA version: 7.0Level: PTClassification code 10008190EUCTR2005-003700-10-BEInstitut de Recherches Internationales Servier18,000
进行中（未招募）
不适用
Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack.The PERFORM Study.An international, randomised, double-blind, two parallel group study comparing terutroban 30 mg o.d. versus aspirin 100 mg o.d. administered orally for a 3-year mean duration (event driven trial). - PERFORMEUCTR2005-003700-10-LTInstitut de Recherches Internationales Servier18,000
进行中（未招募）
不适用
Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack.The PERFORM Study.An international, randomised, double-blind, two parallel group study comparing terutroban 30 mg o.d. versus aspirin 100 mg o.d. administered orally for a 3-year mean duration (event driven trial). - PERFORMIschaemic stroke or transient ischaemic attackMedDRA version: 7.0Level: PTClassification code 10008190EUCTR2005-003700-10-DEInstitut de Recherches Internationales Servier18,000
进行中（未招募）
不适用
Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack.The PERFORM Study.An international, randomised, double-blind, two parallel group study comparing terutroban 30 mg o.d. versus aspirin 100 mg o.d. administered orally for a 3-year mean duration (event driven trial). - PERFORMEUCTR2005-003700-10-SEInstitut de Recherches Internationales Servier18,000
进行中（未招募）
不适用
Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack.The PERFORM Study.An international, randomised, double-blind, two parallel group study comparing terutroban 30 mg o.d. versus aspirin 100 mg o.d. administered orally for a 3-year mean duration (event driven trial). - PERFORMIschaemic stroke or transient ischaemic attackMedDRA version: 7.0Level: PTClassification code 10008190EUCTR2005-003700-10-HUInstitut de Recherches Internationales Servier18,000