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Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF (OASIS-AF)

20. maj 2026 opdateret af: Min Lou, Second Affiliated Hospital, School of Medicine, Zhejiang University

A Prospective, Multicenter, Randomized Controlled Trial of Anticoagulation Therapy After Ischemic Stroke in Patients With Previous Intracerebral Hemorrhage and Atrial Fibrillation

This prospective, multicenter, randomized controlled trial aims to evaluate the efficacy and safety of initiating direct oral anticoagulants (DOACs) in patients with a history of spontaneous intracerebral hemorrhage (ICH) and non-valvular atrial fibrillation (AF) who have recently suffered an acute ischemic stroke. Existing evidence regarding the optimal antithrombotic strategy for this specific high-risk "double-jeopardy" population remains largely undefined. Eligible participants will be randomized in a 1:1 ratio to either receive oral anticoagulation therapy or a non-anticoagulation standard of care. The primary objective is to assess the incidence of a composite endpoint consisting of recurrent ischemic stroke and recurrent ICH over a 12-month follow-up period.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

852

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Min Lou, PhD, MD
  • Telefonnummer: 8613958007213
  • E-mail: lm99@zju.edu.cn

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Diagnosis of acute ischemic stroke, with no evidence of hemorrhagic transformation confirmed by acute neuroimaging (MRI and CT).
  3. Documented history of spontaneous intracerebral hemorrhage (ICH).
  4. Confirmed non-valvular atrial fibrillation (including paroxysmal, persistent, or permanent subtypes).
  5. Provision of written informed consent by the patient or a legally authorized representative.

Exclusion Criteria:

  1. Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score > 4.
  2. Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases.
  3. Severe, uncontrolled hypertension refractory to medical therapy.
  4. Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) < 30 mL/min.
  5. Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism).
  6. Documented contraindications to direct oral anticoagulants according to the product summary of characteristics (excluding the previous spontaneous ICH), including but not limited to hypersensitivity, active clinically significant bleeding, high-risk bleeding lesions, or hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
  7. Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device.
  8. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
  9. Estimated life expectancy of less than 1 year due to concomitant terminal illness.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Anticoagulation Therapy
Participants in this arm will receive early initiation of direct oral anticoagulants (DOACs) following an individualized clinical assessment. Initiation is contingent upon the exclusion of hemorrhagic transformation via head CT/SWI within 24 hours prior to treatment.
Medicin: Direct Oral Anticoagulants (DOACs)
Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.
Aktiv komparator: Non-Anticoagulation Therapy
Participants will not receive oral anticoagulation therapy during the study period. Patients may be prescribed single antiplatelet therapy (e.g., aspirin or clopidogrel) or no antithrombotic therapy, strictly at the discretion of the treating physician based on current clinical guidelines and individual patient risk profiles.
Medicin: Antiplatelet Therapy or No Antithrombotic Therapy
Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of the Composite Endpoint of Recurrent Stroke
Tidsramme: Up to 12 months
Proportion of participants experiencing a recurrent ischemic stroke or a recurrent intracerebral hemorrhage (ICH). Events will be adjudicated by independent, blinded clinical assessors.
Up to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Recurrent Ischemic Stroke
Tidsramme: Up to 12 months.
Proportion of participants experiencing a recurrent acute ischemic stroke.
Up to 12 months.
Incidence of Recurrent Intracerebral Hemorrhage (ICH)
Tidsramme: Up to 12 months.
Proportion of participants experiencing a recurrent spontaneous ICH.
Up to 12 months.
Time to First Occurrence of Recurrent Ischemic Stroke
Tidsramme: Up to 12 months
Time interval from randomization to the confirmed diagnosis of a recurrent ischemic stroke.
Up to 12 months
Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH)
Tidsramme: Up to 12 months
Time interval from randomization to the confirmed diagnosis of a recurrent ICH.
Up to 12 months
Incidence of Vascular Death
Tidsramme: Up to 12 months
Proportion of participants who die from vascular causes (e.g., fatal stroke, fatal myocardial infarction).
Up to 12 months
All-Cause Mortality Rate
Tidsramme: Up to 12 months
Proportion of participants who die from any cause during the follow-up period.
Up to 12 months
Incidence of Major Bleeding Events
Tidsramme: Up to 12 months
Proportion of participants experiencing a major bleeding event, defined strictly according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.
Up to 12 months
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding
Tidsramme: Up to 12 months
Proportion of participants experiencing bleeding events that do not meet the ISTH criteria for major bleeding but result in medical intervention, hospitalization, or discontinuation of the study drug.
Up to 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Efterforskere

  • Ledende efterforsker: Min Lou, PhD, MD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

1. september 2029

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

20. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OASIS-AF

Plan for individuelle deltagerdata (IPD)

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