Anticoagulation Length in Cancer Associated Thrombosis (ALICAT)
|ClinicalTrials.gov Identifier: NCT01817257|
Recruitment Status : Terminated (Early findings showed trial was not feasible)
First Posted : March 25, 2013
Last Update Posted : January 31, 2018
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|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|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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.
No Intervention: B: Discontinue treatment
Discontinue low molecular weight heparin (LMWH) once patient has received six months treatment following index VTE case.
- 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 ]
- Completion of trial protocol [ Time Frame: 24 months ]
- Quality of life [ Time Frame: 24 months ]
- 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.
- 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.
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
|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)|
|Cardiff, United Kingdom|
|Aneurin Bevan Health Board (Royal Gwent Hospital)|
|Newport, United Kingdom|
|South Warwickshire NHS Foundation Trust (Warwick Hospital)|
|Warwick, United Kingdom|
|Principal Investigator:||Simon Noble, Dr||Cardiff University|