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:
Collaborator:
The Stroke Association, United Kingdom
Information provided by (Responsible Party):
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00238667
First received: October 11, 2005
Last updated: May 19, 2015
Last verified: September 2005
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT00238667     History of Changes
Other Study ID Numbers: CAMER5UA, 2006-002827-18, 04.0287, 04/Q0803/15, 04/Q0803/215, TSA2004/16
Study First Received: October 11, 2005
Last Updated: May 19, 2015
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Aneurysm, Dissecting
Vertebral Artery Dissection
Aneurysm
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Cerebrovascular Trauma
Nervous System Diseases
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries
Anticoagulants
Aspirin
Calcium heparin
Clopidogrel
Dipyridamole
Heparin
Warfarin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents

ClinicalTrials.gov processed this record on September 01, 2015