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Anticoagulation Length in Cancer Associated Thrombosis (ALICAT)

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ClinicalTrials.gov Identifier: NCT01817257
Recruitment Status : Unknown
Verified March 2013 by Lisette Nixon, Cardiff University.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2013
Last Update Posted : March 25, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a two year, multicentre, mixed methods feasibility study including a randomised controlled two-arm interventional trial, a nested qualitative study, focus groups and a United Kingdom (UK) wide survey exercise.

Condition or disease Intervention/treatment Phase
Cancer Thrombosis Venous Thromboembolism Deep Vein Thrombosis Pulmonary Embolus Drug: Low Molecular Weight Heparin (LMWH) Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Feasibility Study to Inform the Design of a Randomised Controlled Trial to Identify the Most Clinically and Cost Effective Length of Anticoagulation With Low Molecular Weight Heparin In the Treatment of Cancer Associated Thrombosis
Study Start Date : March 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A: Continue treatment
Continue low molecular weight heparin (LMWH) at treatment dose according to body weight for further six months.
Drug: Low Molecular Weight Heparin (LMWH)
Participants randomised to Arm A will have already received LMWH (Fragmin®), tinzaparin (Innohep®) or enoxaparin (Clexane®) at treatment dose for six months off trial, and should continue the same drug at the same dose for a further six months on trial. No dose alterations are required unless clinically indicated.
Other Names:
  • Dalteparin (Fragmin®)
  • Tinzaparin (Innohep®)
  • Enoxaparin (Clexane®)
No Intervention: B: Discontinue treatment
Discontinue low molecular weight heparin (LMWH) once patient has received six months treatment following index VTE case.

Outcome Measures

Primary Outcome Measures :
  1. Number of eligible and recruited patients (target recruitment rate of 30% of eligible patients) over 12 months, and proportion of participants with recurrent VTEs during follow-up. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Completion of trial protocol [ Time Frame: 24 months ]
  2. Quality of life [ Time Frame: 24 months ]
  3. Symptom assessment during the study [ Time Frame: 24 months ]
    Toxicities, including bleeding events and VTEs, will be assessed during the 6 month trial treatment period.

  4. Attitudes of clinicians and patients to extended treatment with LMWH [ Time Frame: 24 months ]
    Attitudes of clinicians and patients to extended treatment with LMWH will be assessed through clinician focus groups and qualitative interviews with patients and carers.

Eligibility Criteria

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Receiving LMWH for treatment of CAT for five months
  • Locally advanced or metastatic cancer
  • Able to self-administer LMWH, or have LMWH administered by a carer
  • Able to give informed consent
  • Age ≥16 years

Exclusion Criteria:

  • Receiving drug other than LMWH for CAT
  • Contraindication to anticoagulation
  • Fitted with a prosthetic heart valve
  • Pregnant and/or lactating females
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): NCT01817257

Contact: Joanna D Smith, Dr +44 (0)2920 687463 sealjd@cf.ac.uk
Contact: Angela Casbard, Ms +44 (0)2920 687470 casbardac@cf.ac.uk

United Kingdom
George Eliot Hospital NHS Trust (George Eliot Hospital)
Nuneaton, Warwickshire, United Kingdom
Worcestershire Acute Hospitals NHS Trust (Worcester Royal Hospital)
Worcester, Worcestershire, United Kingdom
Velindre NHS Trust (Velindre Cancer Centre) Not yet recruiting
Cardiff, United Kingdom
Principal Investigator: Simon Noble, Dr         
Aneurin Bevan Health Board (Royal Gwent Hospital)
Newport, United Kingdom
South Warwickshire NHS Foundation Trust (Warwick Hospital) Not yet recruiting
Warwick, United Kingdom
Principal Investigator: Peter Rose, Dr         
Sponsors and Collaborators
Cardiff University
National Institute for Health Research, United Kingdom
Wales Cancer Trials Unit
Principal Investigator: Simon Noble, Dr Cardiff University
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisette Nixon, Senior Trial Manager, Cardiff University
ClinicalTrials.gov Identifier: NCT01817257     History of Changes
Other Study ID Numbers: SPON1037-11
10/145/01 ( Other Grant/Funding Number: NIHR HTA )
2012-004117-14 ( EudraCT Number )
WCTU062 ( Other Identifier: WCTU )
ISRCTN37913976 ( Other Identifier: ISRCTN )
to be assigned ( Other Identifier: NIHR NCRN )
to be assigned ( Other Identifier: EGMS )
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: March 25, 2013
Last Verified: March 2013

Keywords provided by Lisette Nixon, Cardiff University:
Venous thromboembolism
Deep vein thrombosis
Pulmonary embolus

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Venous Thromboembolism
Pulmonary Embolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action