Clinical trial NCT03749057: Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation
Official title: Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation: a Prospective, Multicenter, Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cerebral Infarction
TIA
Keywords: rivaroxaban
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anticoagulant treatment for non-valvular atrial fibrillation (AF) associated with cerebral infarction/ TIA is one of the recognized treatment of stroke prevention. The ACC/AHA and national guidelines for the management of anticoagulation recommend that most of AF patients with cerebral infarction or TIA should be administrated anticoagulant therapy within 14 days of symptom onset, while European guidelines recommend that the timing of the initiation of non-vitamin K antagonist oral anticoagulants (NOACs) for AF patients with cerebral infarction or TIA is association with stroke severity in light of the "1-3-6-12" principle. However, there are still many problems about the use of NOACs in ischemic stroke with AF. for example, it is unclear what time to begin NOACs as to difference in stroke severity, ages, comorbidity with hypertension, diabetes, heart failure, liver and kidney dysfunction and bleeding risks. Thus, the timing of the initiation of NOACs is yet to be further studied. Current urgent need is to develop a guideline-based specific regimen in which the benefit-risk factors are further balanced with a combination of NHISS, CHA2DS2-VASC and HAS-BLED score.

Rivaroxaban, a direct coagulation factor Ⅹa inhibitor, blocks the formation of the clot. ROCKET-AF study has shown that the efficacy of rivaroxaban is not inferior to that of warfarin in AF patients on stroke prevention, and rivaroxaban has a significantly decreased bleeding risk compared with warfarin. Recent study indicates that early administration with rivaroxaban for AF patients within 14 days of onset does not significantly increase hemorrhagic transformation. However, the relevant clinical data of the efficacy and safety of early initiation of rivaroxaban in AF patients with cerebral infarction or TIA are lacking in China.

Therefore, the investigators conduct a multicenter cohort study to investigate the safety of early rivaroxaban in the AF patient with cerebral infarction or TIA within 12 days of onset.


Eligibility criteria: Inclusion criteria:

1. Over 18 years
2. Acute cerebral infarction caused by non-valvular atrial fibrillation
3. NIHSS score ≤ 15
4. Within 12 days of onset
5. first stroke onset or past stroke without obvious neurological deficit (mRS score≤1)
6. Signed informed consent

Exclusion Criteria:

1. Hemorrhagic stroke or mixed stroke
2. Patients with valvular atrial fibrillation or non-cardiogenic cerebral infarction
3. Patients with severe infection or serious diseases
4. Gastrointestinal bleeding or major operation within 3 months
5. Planed cerebrovascular reconstruction or cardiac surgery within 3 months
6. Planed major surgery within 3 months
7. Participating in other clinical trials within 3 months
8. Unsuitable for this trial assessed by research

Primary outcomes:
measure: incidence of intracranial hemorrhage
timeFrame: 7 days
Secondary outcomes:
measure: incidence of early neurological deterioration
timeFrame: 7 days
measure: recurrence of stroke or other vascular events
timeFrame: 90 days
measure: bleeding event
timeFrame: 90 days
measure: Serious adverse events
timeFrame: 90 days
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of ShenYang Military Region
Study officials:
affiliation: Neurology Department
name: Huisheng Chen, Doctor
role: STUDY_CHAIR
References: