Image

Early Versus Late Initiation of Anticoagulation in Mild-to-moderate AIS Patients With NVAF

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

Inclusion Criteria:

  • Age > 18 years old
  • Acute ischemic stroke with onset < 48 hours
  • Have a history or newly diagnosed as NVAF
  • NIHSS on admission <= 8

Exclusion Criteria:

  • 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
  • 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.

Study details

Acute Ischemic Stroke, Atrial Fibrillation

NCT06057467

Second Affiliated Hospital, School of Medicine, Zhejiang University

20 March 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.