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To Determine the Feasibility of a Clinical Trial Comparing Anticoagulants Versus Antiplatelets in the Acute Treatment of Patients With Cervical Artery Dissection (CADISS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00238667
First Posted: October 13, 2005
Last Update Posted: May 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Stroke Association, United Kingdom
Information provided by (Responsible Party):
St George's, University of London
  Purpose
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.

Condition Intervention Phase
Cervical Artery Dissection Carotid Artery Dissection Vertebral Artery Dissection Stroke Drug: Antiplatelet (Aspirin, Dipyridamole, clopidogrel) Drug: Anticoagulant (Unfractionated Heparin, LMW Heparin, Warfarin) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cervical Artery Dissection in Stroke Study

Resource links provided by NLM:


Further study details as provided by St George's, University of London:

Enrollment: 250
Study Start Date: November 2005
Study Completion Date: May 2014
Arms Assigned Interventions
Active Comparator: Anti-platelet therapy
Aspirin, Dipyridamole, clopidogrel alone or in dual therapy
Drug: Antiplatelet (Aspirin, Dipyridamole, clopidogrel)
Other Name: Aspirin, Dipyridamole, clopidogrel
Active Comparator: Anti-coagulant
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)
Other Name: Unfractionated Heparin, LMW Heparin, Warfarin

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Extracranial carotid or vertebral artery dissection with symptom onset within the last 7 days. This includes:

    1. Ipsilateral transient ischemic attack or stroke
    2. Ipsilateral Horner's syndrome or neck pain with known date of onset.
  2. Imaging evidence of definite or probable dissection on MRI/MRA, CTA or ultrasound.

Exclusion Criteria:

  1. Intracranial cerebral artery dissection
  2. Symptom onset after 7 days
  3. Contraindication to either antiplatelet agents or anticoagulation therapy
  4. Patient's refusal to consent
  5. Patients who are undergoing angiography and stenting or surgery for treatment of their dissection.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238667


Locations
United Kingdom
St. George's University of London, Clinical Neuroscience Department, Cranmer Terrace
London, England, United Kingdom, SW17 0RE
Sponsors and Collaborators
St George's, University of London
The Stroke Association, United Kingdom
Investigators
Principal Investigator: 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
  More Information

Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT00238667     History of Changes
Other Study ID Numbers: CAMER5UA
2006-002827-18 ( EudraCT Number )
04.0287 ( Other Identifier: Sponsor St Georges University of London )
04/Q0803/15 ( Other Identifier: REC/IRB reference )
04/Q0803/215 ( Other Identifier: REC/IRB reference )
TSA2004/16
First Submitted: October 11, 2005
First Posted: October 13, 2005
Last Update Posted: May 20, 2015
Last Verified: September 2005

Keywords provided by St George's, University of London:
Extracranial carotid artery dissection
Dissection and stroke

Additional relevant MeSH terms:
Stroke
Aneurysm, Dissecting
Vertebral Artery Dissection
Carotid Artery, Internal, Dissection
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aneurysm
Cerebrovascular Trauma
Trauma, Nervous System
Wounds and Injuries
Carotid Artery Injuries
Carotid Artery Diseases
Aspirin
Ticlopidine
Heparin
Calcium heparin
Clopidogrel
Dipyridamole
Warfarin
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs