Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime (RASUNOA-Prime)

• ClinicalTrials.gov Identifier: NCT02533960
• Recruitment Status: Completed
• First Posted: August 27, 2015
• Last Update Posted: November 2, 2022
• Sponsor: University Hospital Heidelberg
• Collaborators: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma; Boehringer Ingelheim; Bristol-Myers Squibb; Daiichi Sankyo, Inc.; University of Wuerzburg
• Information provided by (Responsible Party): Prof. Roland Veltkamp, University Hospital Heidelberg

Tracking Information

• First Submitted Date: August 23, 2015
• First Posted Date: August 27, 2015
• Last Update Posted Date: November 2, 2022
• Actual Study Start Date: June 2015
• Actual Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 26, 2015)

• Primary hypothesis (ischemic stroke substudy) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks" ]
  Intracerebral hemorrhage complications (i.e. sICH, according to NINDS and SITS-MOST)
• Primary hypothesis (hemorrhagic stroke substudy) [ Time Frame: 24 hours ]
  Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of >= 33% or 6 mL)

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
• Official Title: Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime
• 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.

Detailed Description

The main purpose of this observational cohort study is to assess routine emergency management of acute stroke patients with AF under different anticoagulation schemes before the index stroke.

The investigators will address the following aims and objectives:

1. Describing emergency management of stroke patients (IS and ICH) with AF in clinical routine including early diagnostic, therapeutic and preventive procedures and assessing variations in emergency management of patients with AF by anticoagulation schemes pre stroke.
2. Identifying variations in risk of early complications (e.g. symptomatic secondary intracerebral haemorrhage in ischemic stroke patients) with AF by different anticoagulation schemes pre stroke.
3. Determining factors influencing outcome of stroke patients with AF at three months and clarifying the potential influence of different anticoagulation schemes pre stroke.

The registry consists of 2 separate substudies that cover two different patient cohorts: ischemic stroke and intracerebral hemorrhage.

The study will collect information from prospectively enrolling Neurology departments with certified stroke units across Germany.

The principal investigator, Prof. Dr. med. Roland Veltkamp, is affiliated with Imperial College London, UK, and Heidelberg University Hospital, Germany.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

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

Intervention

Other: not applicable (observational study)

Observational study without study related intervention.

Study Groups/Cohorts

• 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).

  Intervention: 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)

  Intervention: 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.

  Intervention: Other: not applicable (observational study)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2021): 3832
• Original Estimated Enrollment (submitted: August 26, 2015): 4000
• Actual Study Completion Date: June 2022
• Actual Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Ischemic stroke substudy:

Inclusion Criteria:

• 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

Exclusion Criteria:

• No informed consent
• Symptom-onset > 24 h

Hemorrhagic stroke substudy:

Inclusion Criteria:

• Age >= 18 years
• Acute primary intracerebral hemorrhage
• - a) Anticoagulation with NOAC
• - b) Anticoagulation with VKA
• - c) No anticoagulation
• Previous/present atrial fibrillation

Exclusion Criteria:

• No informed consent
• Symptom-onset > 24 h

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02533960
• Other Study ID Numbers: RASUNOA-Prime
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof. Roland Veltkamp, University Hospital Heidelberg
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital Heidelberg
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Roland Veltkamp, Prof. Dr. med.; Heidelberg University Hospital, Department of Neurology, Heidelberg, Germany; Department of Stroke Medicine, Imperial College London, London, United Kingdom.

• PRS Account: University Hospital Heidelberg
• Verification Date: November 2022