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Not yet recruiting NCT07609654

Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF

Phase IV Interventional Acute Ischemic Stroke Intracerebral Hemorrhage Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Direct Oral Anticoagulants (DOACs), Antiplatelet Therapy or No Antithrombotic Therapy.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke, Intracerebral Hemorrhage, Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Direct Oral Anticoagulants (DOACs)
    Administration of approved DOACs (e.g., apixaban, rivaroxaban, edoxaban, or dabigatran) at standard stroke prevention dosages.
  • Drug Antiplatelet Therapy or No Antithrombotic Therapy
    Administration of single antiplatelet agents or avoidance of antithrombotic therapy, representing the current variable standard of care.

Primary outcome measures

  • Incidence of the Composite Endpoint of Recurrent Stroke [Time frame: Up to 12 months]
Secondary outcome measures (8)
  • Incidence of Recurrent Ischemic Stroke [Time frame: Up to 12 months.]
  • Incidence of Recurrent Intracerebral Hemorrhage (ICH) [Time frame: Up to 12 months.]
  • Time to First Occurrence of Recurrent Ischemic Stroke [Time frame: Up to 12 months]
  • Time to First Occurrence of Recurrent Intracerebral Hemorrhage (ICH) [Time frame: Up to 12 months]
  • Incidence of Vascular Death [Time frame: Up to 12 months]
  • All-Cause Mortality Rate [Time frame: Up to 12 months]
  • Incidence of Major Bleeding Events [Time frame: Up to 12 months]
  • Incidence of Clinically Relevant Non-Major (CRNM) Bleeding [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Severe baseline disability, defined as a pre-stroke Modified Rankin Scale (mRS) score > 4.
  • Intracerebral hemorrhage definitively caused by underlying structural vascular lesions (e.g., AVM, aneurysm) or systemic diseases.
  • Severe, uncontrolled hypertension refractory to medical therapy.
  • Severe renal impairment, defined as an estimated Creatinine Clearance (CrCl) < 30 mL/min.
  • Clinical indications necessitating continuous oral anticoagulation therapy other than atrial fibrillation (e.g., mechanical prosthetic heart valves, deep vein thrombosis, pulmonary embolism).
  • 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.
  • Prior deployment of, or planned procedure for, a left atrial appendage occlusion (LAAO) device.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
  • Estimated life expectancy of less than 1 year due to concomitant terminal illness.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07609654 · OASIS-AF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗