Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime

NCT02533960 | Completed

• 1 other identifier: RASUNOA-Prime
• Study Type: observational
• Target: 3,832
• Locations: 1 country
• Sites: 1

Brief Summary

The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an investigator-initiated study, is a German multicenter, prospective, observational registry. It is performed at about 50 certified stroke-units and supported by an unrestricted grant from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime is designed to assess the emergency management of acute ischemic and hemorrhagic stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke: Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no anticoagulation.

Conditions

Ischemic Stroke; Intracerebral Hemorrhage; Oral Anticoagulation; Cardiovascular Diseases; Vascular Diseases

Keywords

Registry of Acute Stroke Under Novel Oral Anticoagulants

Outcome Measures

Primary Outcomes (2)

• Primary hypothesis (ischemic stroke substudy)

  Intracerebral hemorrhage complications (i.e. sICH, according to NINDS and SITS-MOST)

  Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks"

• Primary hypothesis (hemorrhagic stroke substudy)

  Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of \>= 33% or 6 mL)

  24 hours

Study Arms (3)

NOAC

Ischemic stroke substudy: inclusion of 1000 patients under treatment with non-vitamin K antagonist oral anticoagulants (NOACs). Hemorrhagic stroke substudy: inclusion of 334 patients under treatment with non-vitamin K antagonist oral anticoagulants (NOACs).

Other: not applicable (observational study)

VKA

Ischemic stroke substudy: inclusion of 1000 patients under treatment with vitamin K antagonists (VKA). Hemorrhagic stroke substudy: inclusion of 333 patients under treatment with vitamin K antagonists (VKA)

Other: not applicable (observational study)

Without OAC

Ischemic stroke substudy: inclusion of 1000 patients without oral anticoagulation. Hemorrhagic stroke substudy: inclusion of 333 patients without oral anticoagulation.

Other: not applicable (observational study)

Interventions

not applicable (observational study) OTHER

Observational study without study related intervention.

NOAC; VKA; Without OAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke \[Non-vitamin K antagonists oral anticoagulants (NOAC, also referred to as novel or new oral anticoagulants), Vitamin K antagonists (VKA), and no oral anticoagulation. According to the type of stroke, patients will be enrolled in the ischemic or hemorrhagic stroke substudy. NOTE: As of July 2019, enrollment in the ischemic stroke substudy was terminated due to achievement of the targeted enrolling numbers. NOTE: As of April 2021, enrollment in the intracerebral hemorrhage substudy was terminated due to achievement of the targeted enrolling numbers.

You may qualify if:

• Age \>= 18 years
• Informed consent
• Acute ischemic stroke with either symptoms lasting ≥ 24h or evidence of infarction in brain imaging
• Anticoagulation with NOAC
• Anticoagulation with VKA
• No anticoagulation
• Previous/present atrial fibrillation

You may not qualify if:

• No informed consent
• Symptom-onset \> 24 h
• Hemorrhagic stroke substudy:
• Age \>= 18 years
• Acute primary intracerebral hemorrhage
• \- a) Anticoagulation with NOAC
• \- b) Anticoagulation with VKA
• \- c) No anticoagulation
• Previous/present atrial fibrillation
• No informed consent
• Symptom-onset \> 24 h

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator
• Boehringer Ingelheim: collaborator
• Bristol-Myers Squibb: collaborator
• Daiichi Sankyo: collaborator
• University of Wuerzburg: collaborator

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (1)

• Haas K, Purrucker JC, Rizos T, Heuschmann PU, Veltkamp R. Rationale and design of the Registry of Acute Stroke Under Novel Oral Anticoagulants-prime (RASUNOA-prime). Eur Stroke J. 2019 Jun;4(2):181-188. doi: 10.1177/2396987318812644. Epub 2018 Dec 17.

  PMID: 31259266 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Cardiovascular Diseases; Vascular Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Roland Veltkamp, Prof. Dr. med.

  Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2015
• First Posted: August 27, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2022
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

DE (1)