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Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF (ASAP)

Primary Purpose

Acute Ischemic Stroke, Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anticoagulation Agents
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 18 years old Acute ischemic stroke with onset < 48 hours Have a history or newly diagnosed as NVAF NIHSS on admission <= 8 Exclusion Criteria: Chronic renal dysfunction (GFR < 30ml/min) or severe hepatic injury Have a history or newly diagnosed as valvular heart disease Mural thrombus in heart Contraindications of anticoagulation therapy within 12 days after AIS, e.g. severe intracranial hemorrhage Received reperfusion therapy, e.g. intravenous thrombolysis and endovascular treatment Concomitant stenosis (>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory Life expectancy less than 1 year Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding Pregnant or lactating women Individuals identified by researchers as unsuitable for participation in the study due to other reasons.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early initiation of anticoagulation

Late initiation of anticoagulation

Arm Description

For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 0-3 days of onset. For patients with NIHSS 4-8, anticoagulation therapy will be initiated within 4-6 days of onset.

For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 4-12 days of onset. For patients with NIHSS 4-8, anticoagulation therapy will be initiated within 7-12 days of onset.

Outcomes

Primary Outcome Measures

Early neurological deterioration before discharge
NIHSS at discharge increase at least 2 points compared with NIHSS on admission

Secondary Outcome Measures

90-day Composite events
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment
90-day ischemic stroke
Ischemic stroke within 90 days after enrollment
90-day hemorrhagic stroke
Hemorrhagic stroke within 90 days after enrollment
90-day myocardial infarction
Myocardial infarction within 90 days after enrollment
90-day systemic embolism
Systemic embolism within 90 days after enrollment
90-day major extracranial hemorrhage
Major extracranial hemorrhage within 90 days after enrollment
90-day non-major bleeding
Non-major bleeding within 90 days after enrollment
90-day vascular death
Vascular death within 90 days after enrollment
90-day all-cause death
All-cause death within 90 days after enrollment
Discharge mRS
Modified Rankin scale at discharge

Full Information

First Posted
September 13, 2023
Last Updated
October 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT06057467
Brief Title
Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF
Acronym
ASAP
Official Title
Early Versus Late Initiation of Anticoagulation in Mild-to-moderate Acute Ischemic Stroke Patients With Non-valvular Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in acute ischemic stroke (AIS) patients with non-valvular atrial fibrillation (NVAF). Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is early neurological deterioration (END) before discharge.
Detailed Description
Anticoagulation therapy is effective to prevent ischemic stroke in patients with NVAF who have a history of stroke. Recent clinical trials have demonstrated that early initiation of anticoagulation therapy after AIS is safe, while no remarkable benefits have been observed. The goal of this clinical trial is to compare the effectiveness between early and late initiation of anticoagulation therapy in AIS patients with non-NVAF. Participants will be 1:1 randomized into early or late initiation group. The primary endpoint is END before discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke, Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2351 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early initiation of anticoagulation
Arm Type
Experimental
Arm Description
For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 0-3 days of onset. For patients with NIHSS 4-8, anticoagulation therapy will be initiated within 4-6 days of onset.
Arm Title
Late initiation of anticoagulation
Arm Type
Active Comparator
Arm Description
For patients with NIHSS 0-3, anticoagulation therapy will be initiated within 4-12 days of onset. For patients with NIHSS 4-8, anticoagulation therapy will be initiated within 7-12 days of onset.
Intervention Type
Drug
Intervention Name(s)
Anticoagulation Agents
Intervention Description
Anticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban.
Primary Outcome Measure Information:
Title
Early neurological deterioration before discharge
Description
NIHSS at discharge increase at least 2 points compared with NIHSS on admission
Time Frame
At discharge, an average of 7 days
Secondary Outcome Measure Information:
Title
90-day Composite events
Description
Composite events including ischemic stroke, hemorrhagic stroke, myocardial infarction, systemic embolism, major extracranial hemorrhage, and vascular death within 90 days after enrollment
Time Frame
90 days
Title
90-day ischemic stroke
Description
Ischemic stroke within 90 days after enrollment
Time Frame
90 days
Title
90-day hemorrhagic stroke
Description
Hemorrhagic stroke within 90 days after enrollment
Time Frame
90 days
Title
90-day myocardial infarction
Description
Myocardial infarction within 90 days after enrollment
Time Frame
90 days
Title
90-day systemic embolism
Description
Systemic embolism within 90 days after enrollment
Time Frame
90 days
Title
90-day major extracranial hemorrhage
Description
Major extracranial hemorrhage within 90 days after enrollment
Time Frame
90 days
Title
90-day non-major bleeding
Description
Non-major bleeding within 90 days after enrollment
Time Frame
90 days
Title
90-day vascular death
Description
Vascular death within 90 days after enrollment
Time Frame
90 days
Title
90-day all-cause death
Description
All-cause death within 90 days after enrollment
Time Frame
90 days
Title
Discharge mRS
Description
Modified Rankin scale at discharge
Time Frame
At discharge, an average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years old Acute ischemic stroke with onset < 48 hours Have a history or newly diagnosed as NVAF NIHSS on admission <= 8 Exclusion Criteria: Chronic renal dysfunction (GFR < 30ml/min) or severe hepatic injury Have a history or newly diagnosed as valvular heart disease Mural thrombus in heart Contraindications of anticoagulation therapy within 12 days after AIS, e.g. severe intracranial hemorrhage Received reperfusion therapy, e.g. intravenous thrombolysis and endovascular treatment Concomitant stenosis (>50%) of carotid artery/intracranial artery, of which the ischemic lesion located within the territory Life expectancy less than 1 year Plan to receive invasive surgery in the following 3 months and have high risk of uncontrollable bleeding Pregnant or lactating women Individuals identified by researchers as unsuitable for participation in the study due to other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Lou, PhD
Phone
+8613958007213
Email
loumingxc@vip.sina.com
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Lou, PhD
Phone
8657187784811
Email
loumingxc@vip.sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF

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