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New treatment option for Ischemic Stroke
Official title Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation 2
ClinicalTrials.gov ID: NCT07139314
What this study is testing
What is Early anticoagulation?
Early anticoagulation is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study evaluates the safety and efficacy of early versus delayed initiation of direct oral anticoagulants (DOACs) in patients with acute ischemic stroke related to atrial fibrillation who develop hemorrhagic transformation after endovascular treatment.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged 18 years or over.
- Clinical diagnosis of large vessel occlusion acute ischemic stroke.
- Emergency endovascular treatment was performed within 24 hours of stroke onset.
- Atrial fibrillation (including paroxysmal, persistent or permanent atrial fibrillation), confirmed by at least one of the following:
- 12-lead ECG recording;
You likely can't join if
- Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).
- Contraindication to the use of direct oral anticoagulants (DOACs):
- Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors;
- Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation);
- Severe renal impairment (defined as creatinine exceeding 1.5 times of the upper limit of normal range) and significant hepatic dysfunction (defined...
- Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4...
See the full eligibility criteria
- Aged 18 years or over.
- Clinical diagnosis of large vessel occlusion acute ischemic stroke.
- Emergency endovascular treatment was performed within 24 hours of stroke onset.
- Atrial fibrillation (including paroxysmal, persistent or permanent atrial fibrillation), confirmed by at least one of the following:
- 12-lead ECG recording;
- Inpatient ECG telemetry;
- Prolonged ECG monitoring (e.g. Holter monitor);
- Previously established diagnosis of atrial fibrillation verified by medical records.
- CT or MRI demonstrating one of the following findings:
- Parenchymatous hematoma type 1: defined as hematoma occupying less than 30% of the infarcted tissue, no substantive mass effect (Heidelberg classification);
- Parenchymatous hematoma type 2: defined as heamtoma occupying 30% or more of the infarcted tissue, with obvious mass effect (Heidelberg classification);
- Intracerebral hemorrhage outside the infarcted brain tissue or intracranial-extracerebral hemorrhage (Heidelberg classification).
- Time from stroke onset to randomization ranged from 7 days to 4 weeks.
- Written informed consent obtained from the patient or a legally authorized representative.
- Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).
- Contraindication to the use of direct oral anticoagulants (DOACs):
- Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors;
- Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation);
- Severe renal impairment (defined as creatinine exceeding 1.5 times of the upper limit of normal range) and significant hepatic dysfunction (defined as ALT or AST \> twice the upper limit of normal range) ;
- Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers;
- Baseline platelet count \< 100 x 109/L;
- History of coagulopathy or systemic hemorrhage.
- Prior DOAC use within 48 hours of stroke onset, or recent treatment with vitamin K antagonist (VKA) leading to INR ≥1.7 at randomization.
- Pregnant or breastfeeding women, or positive pregnancy test at admission.
- History of major surgery or severe trauma within 1 month prior to stroke onset.
- History of active bleeding within 1 month prior to stroke onset (e.g. gastrointestinal bleeding, urinary tract bleeding).
- Dual antiplatelet therapy at baseline, or strong likelihood of requiring dual antiplatelet therapy during the trial.
- Evidence of cerebral amyloid angiopathy.
- CT or MRI evidence of non-stroke pathology likely to account for the presenting clinical symptoms (e.g. mass lesion, encephalitis).
- Modified Rankin scale (mRS) score \> 1 prior to stroke onset.
- Inability to complete the 90-day follow-up.
- Currently participating in another drug clinical trial.
- Any other reason deemed by the investigator to make the patient unsuitable for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Ma’anshan, Anhui, China
- Beijing, Beijing Municipality, China
- Zhangzhou, Fujian, China
- Heyuan, Guangdong, China
- Qinzhou, Guangxi, China
- Baoding, Hebei, China
- Harbin, Heilongjiang, China
- Jiamusi, Heilongjiang, China
- Nanyang, Henan, China
- Pingdingshan, Henan, China
- Xinyang, Henan, China
- Zhumadian, Henan, China
- Wuhan, Hubei, China
- Yangzhou, Jiangsu, China
- Yingkou, Liaoning, China
- Ordos, Neimenggu, China
- Feicheng, Shandong, China
- Jinan, Shandong, China
- Laizhou, Shandong, China
- Linyi, Shandong, China
+ 13 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ma’anshan, Anhui, China; Beijing, Beijing Municipality, China; Zhangzhou, Fujian, China; Heyuan, Guangdong, China; Qinzhou, Guangxi, China; Baoding, Hebei, China and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.