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Deep Vein ThrombosisSTEP-CATNCT02752607

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

An observational study of Deep Vein Thrombosis, run by Dr. Vicky Tagalakis at 7 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deep Vein Thrombosis
How many people
52 participants
Where
7 sitesCanada
Study dates
May 2016to 9 Nov 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Hôpital Charles-Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • Queen Elizabeth II Medical Centre

    Halifax, Nova Scotia, B3H 1V7

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • St-Mary's Hospital

    Montreal, Quebec, H3T 1M5

  • The McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • Hôpital Sacré-Coeur

    Montreal, Quebec, H4J 1C5

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

About this study

Official title: 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.

Medical subject headings
Venous Thrombosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of recurrent VTE

    Measured: 6 months

Secondary outcomes (4)

  1. Cumulative incidence of major bleeding events

    Measured: 6 months

  2. Cumulative incidence of clinically relevant non-major bleeding events

    Measured: 6 months

  3. Cumulative incidence of minor bleeding events

    Measured: 6 months

  4. Overall survival

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion9 Nov 2018
  4. Study completion9 Nov 2018

Why it stopped: The study was stopped early due to low recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02752607
Sponsor's protocol ID
MM-JGH-16-003
Acronym
STEP-CAT
Status last verified
Nov 2018
First submitted
25 Apr 2016
Last updated
26 Nov 2018
Results posted
No
Individual data sharing
No

Publications

  • Popov J, Coelho S, Carrier M, Sperlich C, Solymoss S, Routhier N, Shivakumar S, Aibibula W, Kahn SR, Tagalakis V. Step down to 6 months of prophylactic-dose low molecular weight heparin after initial full-dose anticoagulation for the treatment of cancer-associated thrombosis (STEP-CAT): A pilot study. J Thromb Haemost. 2022 Aug;20(8):1868-1874. doi: 10.1111/jth.15760. Epub 2022 Jun 9.

    PubMed 35587536

Questions about this trial

What is this clinical trial studying?

An observational study of Deep Vein Thrombosis, run by Dr. Vicky Tagalakis at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The study was stopped early due to low recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of recurrent VTE (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02752607, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.

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STEP-CAT Clinical Trial NCT02752607 | AzTrials