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NCT06168838: AAIHINNN
Anticoagulant-associated Intracranial Hemorrhage
trial testing Anticoagulant in Anticoagulant-induced Bleeding in 1,200 participants. Status unknown.
31 January 2024
Quick facts
| Lead sponsor | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,200 |
| Start date | 9 August 2023 |
| Primary completion | 31 January 2024 |
| Estimated completion | 31 January 2024 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Anticoagulant — full drug profile →
Conditions studied
- Anticoagulant-induced Bleeding — all drugs for Anticoagulant-induced Bleeding →
- Intracranial Hemorrhages — all drugs for Intracranial Hemorrhages →
Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez — full company profile →
Who can join
Eligibility, any sex, with Anticoagulant-induced Bleeding or Intracranial Hemorrhages. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06168838
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06168838 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Last refreshed: 13 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06168838.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing