Acute Ischemic StrokeASAPNCT06057467
Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF
A study testing Anticoagulation Agents in people with Acute Ischemic Stroke and Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Atrial Fibrillation
- What is being tested?
- Anticoagulation Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,351 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Acute ischemic stroke with onset < 48 hours
- Have a history or newly diagnosed as NVAF
- NIHSS on admission <= 8
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Min Lou, PhD, 8657187784811, loumingxc@vip.sina.com
- Recruiting
Jiaxing Second Hospital
Jiaxing
Xiaoling Zhang
About this study
Official title: Early Versus Late Initiation of Anticoagulation in Mild-to-moderate Acute Ischemic Stroke Patients With Non-valvular Atrial Fibrillation
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Being tested
- Anticoagulation Agents
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation AgentsDrug
Anticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban.
| Study group | Role | What they receive |
|---|---|---|
| Early initiation of anticoagulation | Experimental | 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. Receives: Drug: Anticoagulation Agents |
| Late initiation of anticoagulation | Active comparator | 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. Receives: Drug: Anticoagulation Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early neurological deterioration before discharge
NIHSS at discharge increase at least 2 points compared with NIHSS on admission
Measured: At discharge, an average of 7 days
Secondary outcomes (10)
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
Measured: 90 days
90-day ischemic stroke
Ischemic stroke within 90 days after enrollment
Measured: 90 days
90-day hemorrhagic stroke
Hemorrhagic stroke within 90 days after enrollment
Measured: 90 days
90-day myocardial infarction
Myocardial infarction within 90 days after enrollment
Measured: 90 days
90-day systemic embolism
Systemic embolism within 90 days after enrollment
Measured: 90 days
90-day major extracranial hemorrhage
Major extracranial hemorrhage within 90 days after enrollment
Measured: 90 days
90-day non-major bleeding
Non-major bleeding within 90 days after enrollment
Measured: 90 days
90-day vascular death
Vascular death within 90 days after enrollment
Measured: 90 days
90-day all-cause death
All-cause death within 90 days after enrollment
Measured: 90 days
Discharge mRS
Modified Rankin scale at discharge
Measured: At discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start15 Sep 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,351 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057467
- Sponsor's protocol ID
- ASAP
- Acronym
- ASAP
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Initiation of Anticoagulation in Mild-to-moderate Acute Ischemic Stroke Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06057467
- Acronym / sponsor ID
- ASAP / ASAP
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,351 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early initiation of anticoagulation | Experimental | Drug: Anticoagulation AgentsFor 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. |
| Late initiation of anticoagulation | Active comparator | Drug: Anticoagulation AgentsFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Acute ischemic stroke with onset < 48 hours
- Have a history or newly diagnosed as NVAF
- NIHSS on admission <= 8
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulation AgentsAnticoagulation agents includes rivaroxaban, dabigatran, apixaban, and edoxaban. | Drug | Early initiation of anticoagulation, Late initiation of anticoagulation |
Primary outcome
Early neurological deterioration before discharge
Time frame: At discharge, an average of 7 days
NIHSS at discharge increase at least 2 points compared with NIHSS on admission
10 secondary outcomes
90-day Composite events
Time frame: 90 days
90-day ischemic stroke
Time frame: 90 days
90-day hemorrhagic stroke
Time frame: 90 days
90-day myocardial infarction
Time frame: 90 days
90-day systemic embolism
Time frame: 90 days
90-day major extracranial hemorrhage
Time frame: 90 days
90-day non-major bleeding
Time frame: 90 days
90-day vascular death
Time frame: 90 days
90-day all-cause death
Time frame: 90 days
Discharge mRS
Time frame: At discharge, an average of 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulation Agents in people with Acute Ischemic Stroke and Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD (+8613958007213, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early neurological deterioration before discharge (time frame: At discharge, an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.