NCT05486351

Brief Summary

This is an observational, prospective, multicenter, cohort study in patients with cardioembolic stroke and previous oral or parenteral anticoagulant therapy. Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted, in terms of stroke or systemic embolism and haemorrhagic transformation.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 3, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 3, 2022

Status Verified

July 1, 2022

Enrollment Period

2.8 years

First QC Date

August 2, 2022

Last Update Submit

August 2, 2022

Conditions

Cardioembolic StrokeAnticoagulant TherapyStroke RecurrenceHaemorrhagic Transformation Stroke

Outcome Measures

Primary Outcomes (2)

  • Ischemic stroke recurrence

    recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging

    90 days

  • Symptomatic haemorrhagic transformation

    Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging

    90 days

Secondary Outcomes (8)

  • Early ischemic stroke recurrence

    Day 1 or day 7

  • Early symptomatic haemorrhagic transformation

    Day 1 or day 7

  • Early radiologic haemorrhagic transformation

    Day 1 or day 7

  • Systemic embolism

    Day 1, day 7 or day 90

  • Major extracraneal haemorrhagic complication

    Day 1, day 7 or day 90

  • +3 more secondary outcomes

Study Arms (2)

Mantainance of anticoagulation therapy

Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained

Other: Observation

Interruption of anticoagulation therapy

Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is interrupted.

Other: Observation

Interventions

ObservationOTHER

Patients are observed for stroke or systemic embolism and haemorrhagic transformation

Interruption of anticoagulation therapyMantainance of anticoagulation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke, with a major cardioembolic source and previosly treated with oral or parental anticoagulants.

You may qualify if:

  • Ischemic stroke of less than 24 hours since beginning of symptoms or last seen normal
  • Mayor cardioembolic source (atrial fibrilation or flutter, mechanical heart valve prosthesis, recient miocardic infarction, rheumatic mitral valve stenosis, dilated cardiomyopathy, atrial myxoma, left ventricular focal akynesia.
  • Previous treatment with oral anticoagulants (vitamin K antagonists or direct oral anticoagulants), having received the last dose within the previous 24 hours. Treatment with intravenous or subcutaneos heparin is also valid.
  • Age \>18 years-old
  • Signed informed consent (by patient or representative)

You may not qualify if:

  • History of Intracraneal or extracraneal haemorrhage that contraindicates anticoagulant therapy
  • Patients treated with intravenous thrombolysis as a reperfusion therapy
  • Intracraneal haemorrhage on initial CT scan
  • Health status with a short survival prevision
  • Patients in which a neurosurgery intervention could be indicated
  • Child-bearing woman or in breast-feeding period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bichat Claude Bernard Hospital

Paris, 75018, France

ACTIVE NOT RECRUITING

Jimenez Diaz Fundation University Hospital

Madrid, 28040, Spain

RECRUITING

La Paz University Hospital

Madrid, 28046, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for levels of anticoagulant medications and/or INR testing

MeSH Terms

Conditions

Embolic Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Ischemic StrokeStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Ricardo Rigual Bobillo, MD

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Rigual Bobillo, MD

CONTACT

917277444ricardojaime.rigual@salud.madrid.org

Elena de Celis Ruiz, MD

CONTACT

917277444elena.decelis.ruiz@idipaz.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 3, 2022

Study Start

March 5, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 3, 2022

Record last verified: 2022-07

Locations

ES(2)FR(1)