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Anticoagulant-associated Intracranial Hemorrhage

NCT06168838 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2023-12-13

No results posted yet for this study

Summary

Oral anticoagulant therapy, including factors Xa and 2a inhibitors has become more popular in recent years due to its efficacy and convenience in preventing thrombotic events and reducing the risk for stroke in patients with rosk factors (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism). These drugs have replaced traditional therapies such as warfarin, which requires frequent dose adjustments and control blood samples. Warfarin also has a higher risk of bleeding events.

Many patients with atrial fibrillation, particularly old patients and those with comorbidities may have trouble achieving the dose and control requirements for warfarin therapy. On the other hand, Direct Oral Anticoagulant therapies do not require a close monitorization and have a lower risk of bleeding events, which makes them a more attractive option for many patients.

There is solid evidence behind the efficacy and safety of Direct Oral Anticoagulant therapies. Multiple clinical trials have demonstrated that Factor Xa inhibitors like rivaroxaban and apixaban are as effective as warfarin in preventing blood clots and reducing stroke risk in patients living with atrial fibrillation.

These challenges remark the need for new research that can improve our comprehension about the risk of bleeding associated to anticoagulant therapies and develop novel and more effective strategies for minimizing this risk.

Hence, an observational analysis about anticoagulant-associated intracranial hemorrhage may help identifying its incidence and prevalence, as well as treatment patterns and identifying any patient with risk factors linked to these events.

This information can be used to improve patient outcomes and guide future research.

Work Hypothesis: The majority of intracranial hemorrhage events are associated with heparin, low molecular weight heparin and warfarin instead of Factor Xa inhibitors or direct thrombin inhibitors. Nevertheless, the growing use in recent years of factor Xa inhibitors can increase the number of this therapy related bleeding events.

Conditions

  • Anticoagulant-induced Bleeding
  • Intracranial Hemorrhages

Interventions

DRUG

Anticoagulant

Know the casuistry of spontaneous intracranial hemorrhages and secondary to the use of both oral and parenteral anticoagulants

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

    lead OTHER

Principal Investigators

  • Claudia Vanessa Cano Nigenda, MD · Instituto Nacional de Neurología y Neurocirugía. Manuel Velasco Suárez

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2024-01-31
Completion
2024-01-31

Countries

  • Mexico

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06168838 on ClinicalTrials.gov