Trial record 1 of 1298 for:    "Thrombosis"
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Anticoagulation Length in Cancer Associated Thrombosis (ALICAT)

This study is not yet open for participant recruitment.
Verified March 2013 by Cardiff University
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Wales Cancer Trials Unit
Information provided by (Responsible Party):
Lisette Nixon, Cardiff University
ClinicalTrials.gov Identifier:
NCT01817257
First received: March 8, 2013
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cardiff University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Completion of trial protocol [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Symptom assessment during the study [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Toxicities, including bleeding events and VTEs, will be assessed during the 6 month trial treatment period.

  • Attitudes of clinicians and patients to extended treatment with LMWH [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Attitudes of clinicians and patients to extended treatment with LMWH will be assessed through clinician focus groups and qualitative interviews with patients and carers.


Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817257

Contacts
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

Locations
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
Investigators
Principal Investigator: Simon Noble, Dr Cardiff University
  More Information

Additional Information:
No publications provided

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, 2012-004117-14, WCTU062, ISRCTN37913976, to be assigned, to be assigned
Study First Received: March 8, 2013
Last Updated: March 20, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

Keywords provided by Cardiff University:
Cancer
Thrombosis
Venous thromboembolism
Deep vein thrombosis
Pulmonary embolus

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Pulmonary Embolism
Thromboembolism
Embolism
Venous Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Tinzaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 20, 2014