Reduction to Preventive Doses of Enoxaparin After 3 to 6 Months of Treatment With Blood Thinners for Cancer-associated Blood Clots (STEP-CAT)

November 21, 2018 updated by: Dr. Vicky Tagalakis

The STEP-CAT Cohort Management Study: Step-down to Prophylactic Doses of Enoxaparin After a Minimum of 3-6 Months of Anticoagulation for the Treatment of Cancer-associated Thrombosis.

Background: Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is the third most common cardiovascular disorder after myocardial infarction and stroke. VTE occurs in about 1 person per 1,000 per year, increasing dramatically in patients with cancer to about 25 per 1,000 per year. Among the known risk factors of VTE, cancer is one of the most potent. Patients with cancer have a 7- to 28-fold higher risk for VTE than non-cancer patients. VTE has important implications for the care of cancer patients, including reduced life expectancy, high rates of VTE recurrence both while on and after stopping anticoagulation, the need for chronic anticoagulation with related adverse drug reactions, and delays in cancer therapies. Clinical dilemma: Current clinical guidelines recommend a minimum of 3-6 months of anticoagulation with weight-adjusted low molecular weight heparin (LMWH) in cancer patients with VTE. However, there are no recommendations beyond the initial 6 months of therapy due to the lack of data on extended duration therapy for cancer-associated thrombosis (CAT). This leads to variability in physician practices, with some continuing weight-adjusted LMWH therapy beyond 6 months. This poses concern because, while the goal is to prevent recurrence of VTE, the risk of major bleeding with prolonged weight-adjusted LMWH therapy is significant. Potential solutions: There is a lack of data to inform on VTE treatment in cancer patients beyond the initial 3-6 months of anticoagulation. We propose that after a minimum of 3-6 months of therapeutic dose anticoagulation, the use of prophylactic doses of LMWH will have an acceptable and adherence profile in cancer patients with VTE. The data obtained from this study will help inform physician practices. Design: This is a multicentre, open-label study of enoxaparin (40 mg subcutaneous injection, once daily) for additional 6 months after an initial minimum 3-6-month course of therapeutic dose anticoagulant therapy. Patients: 150 patients with VTE secondary to cancer will take part in this multicentre study conducted in 8 Canadian centres within Quebec, Ontario and Nova Scotia. Study Outcomes: The primary objective of the study is to determine the rate of recurrent VTE in patients receiving prophylactic dose enoxaparin for secondary VTE prophylaxis after an initial minimum 3-6 months of anticoagulation. The secondary objective is to determine the safety profile of prophylaxis dose enoxaparin for secondary VTE prophylaxis after an initial 3-6 months of anticoagulation. This includes determining for all subjects: 1) cumulative incidence of major bleeding events; 2) cumulative incidence of clinically relevant non-major bleeding events; 3) cumulative incidence of minor bleeding event, and 4) overall survival during follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Medical Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Research Institute
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hôpital Charles-Le Moyne
      • Montreal, Quebec, Canada, H3T 1E2
        • The Jewish General Hospital
      • Montreal, Quebec, Canada, H3T 1M5
        • St-Mary's Hospital
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital Sacre-Coeur
      • Montreal, Quebec, Canada, H4A 3J1
        • The McGill University Health Centre - Glen Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will have an active malignancy defined as any of: a) diagnosis of cancer (excluding basal cell or squamous cell carcinoma) within 18 months of study enrolment; or b) have received treatment for cancer within 18 months (e.g. radiation therapy, chemotherapy, adjuvant therapy) of study enrolment; or c) have documented recurrent or metastatic cancer. Subjects must also have a first episode of objectively confirmed VTE (distal or proximal deep vein thrombosis (DVT) of the lower limb or proximal DVT of the upper limb, or pulmonary embolism (PE)) that is being treated with therapeutic anticoagulation for a minimum intended duration of 3-6 months. Subjects must be ≥18 years of age with a life expectancy of > 6 months.

Description

Inclusion Criteria:

  • Have an active malignancy defined as any of: a) Diagnosis of cancer (excluding basal cell or squamous cell carcinoma of the skin) within 18 months of enrollment; b) Have received treatment for cancer within 18 months (e.g. radiation therapy, chemotherapy, adjuvant therapy); c) Have documented recurrent or metastatic cancer
  • Receiving a 3-6 month course of weight-adjusted LMWH for an acute, objectively confirmed, symptomatic VTE (proximal or distal DVT of the lower extremity, proximal DVT of the upper extremity, or PE)
  • Age ≥ 18 years
  • Life expectancy > 6 months
  • Able to comply with scheduled follow up visits
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Willing to provide written informed consent

Exclusion Criteria:

  • Distal DVT of the upper extremity
  • Recurrent VTE during the 3-6-month LMWH treatment period
  • Major or clinically relevant non-major bleeding during the 3-6 month LMWH treatment period
  • Risk of bleeding (e.g. recent neurosurgery, history of intracranial hemorrhage, acute gastroduodenal ulcer, etc.)
  • Diagnosis of basal cell and squamous cell carcinoma of the skin or acute Leukemia
  • Platelet count < 50 x 109/L
  • Creatinine clearance <30ml/min (using the modified Cockcroft-Gault formula)
  • On hemodialysis
  • Known hypersensitivity to heparin, LMWHs, or pork products
  • Known contraindication to the use of heparin (e.g. heparin-induced thrombocytopenia)
  • Currently participating in another clinical trial involving anticoagulation therapy (with the exception of aspirin)
  • Pregnancy or breastfeeding
  • On an anticoagulant for a different indication
  • Treating physician plans for weight-adjusted LMWH for longer than 3-6 months duration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of recurrent VTE
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival
Time Frame: 6 months
6 months
Cumulative incidence of major bleeding events
Time Frame: 6 months
6 months
Cumulative incidence of clinically relevant non-major bleeding events
Time Frame: 6 months
6 months
Cumulative incidence of minor bleeding events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Vicky Tagalakis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Vicky Tagalakis, MD, MSc, The Lady Davis Insitute, Jewish General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MM-JGH-16-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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