NCT00238667

Brief Summary

This is a feasibility study to determine if a sufficient number of patients can be recruited throughout the United Kingdom and whether sufficient endpoints can be generated for a full scale therapeutic trial of anticoagulants versus antiplatelets in acute cervical artery dissection treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2005

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
8.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 20, 2015

Status Verified

September 1, 2005

First QC Date

October 11, 2005

Last Update Submit

May 19, 2015

Conditions

Cervical Artery DissectionCarotid Artery DissectionVertebral Artery DissectionStroke

Keywords

Extracranial carotid artery dissectionDissection and stroke

Study Arms (2)

Anti-platelet therapy

ACTIVE COMPARATOR

Aspirin, Dipyridamole, clopidogrel alone or in dual therapy

Drug: Antiplatelet (Aspirin, Dipyridamole, clopidogrel)

Anti-coagulant

ACTIVE COMPARATOR

Warfarin, unfractionated heparin, enoxaparin, dalteparin, tinzaparin aiming for an INR in range of 2-3. Local protocols for Heparin can be used

Drug: Anticoagulant (Unfractionated Heparin, LMW Heparin, Warfarin)

Interventions

Antiplatelet (Aspirin, Dipyridamole, clopidogrel)DRUG
Also known as: Aspirin, Dipyridamole, clopidogrel
Anti-platelet therapy
Anticoagulant (Unfractionated Heparin, LMW Heparin, Warfarin)DRUG
Also known as: Unfractionated Heparin, LMW Heparin, Warfarin
Anti-coagulant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Extracranial carotid or vertebral artery dissection with symptom onset within the last 7 days. This includes:
  • Ipsilateral transient ischemic attack or stroke
  • Ipsilateral Horner's syndrome or neck pain with known date of onset.
  • Imaging evidence of definite or probable dissection on MRI/MRA, CTA or ultrasound.

You may not qualify if:

  • Intracranial cerebral artery dissection
  • Symptom onset after 7 days
  • Contraindication to either antiplatelet agents or anticoagulation therapy
  • Patient's refusal to consent
  • Patients who are undergoing angiography and stenting or surgery for treatment of their dissection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. George's University of London, Clinical Neuroscience Department, Cranmer Terrace

London, England, SW17 0RE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Vertebral Artery DissectionStroke

Interventions

AspirinDipyridamoleClopidogrelAnticoagulantsHeparinDalteparinWarfarin

Condition Hierarchy (Ancestors)

Cerebrovascular TraumaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemDissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHematologic AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesGlycosaminoglycansPolysaccharidesCarbohydratesHeparin, Low-Molecular-Weight4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Study Officials

  • Professor John W Norris, MD, FRCP

    St George's, University of London

    PRINCIPAL INVESTIGATOR

  • Professor Hugh Markus, DM, FRCP

    St George's, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 13, 2005

Study Start

November 1, 2005

Study Completion

May 1, 2014

Last Updated

May 20, 2015

Record last verified: 2005-09

Locations

GB(1)