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Trial record 1 of 1 for:    NCT02752607
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Reduction to Preventive Doses of Enoxaparin After 3 to 6 Months of Treatment With Blood Thinners for Cancer-associated Blood Clots (STEP-CAT)

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ClinicalTrials.gov Identifier: NCT02752607
Recruitment Status : Terminated (The study was stopped early due to low recruitment)
First Posted : April 27, 2016
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Dr. Vicky Tagalakis, Lady Davis Institute

Brief 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. 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.

Condition or disease
Deep Vein Thrombosis

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : May 2016
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots




Primary Outcome Measures :
  1. Rate of recurrent VTE [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Cumulative incidence of major bleeding events [ Time Frame: 6 months ]
  2. Cumulative incidence of clinically relevant non-major bleeding events [ Time Frame: 6 months ]
  3. Cumulative incidence of minor bleeding events [ Time Frame: 6 months ]
  4. Overall survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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): NCT02752607


Locations
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Canada, Nova Scotia
Queen Elizabeth II Medical Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Hôpital Charles-Le Moyne
Greenfield Park, Quebec, Canada, J4V 2H1
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
St-Mary's Hospital
Montreal, Quebec, Canada, H3T 1M5
The McGill University Health Centre - Glen Site
Montreal, Quebec, Canada, H4A 3J1
Hôpital Sacré-Coeur
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Dr. Vicky Tagalakis
Sanofi
Investigators
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Study Chair: Vicky Tagalakis, MD, MSc The Lady Davis Insitute, Jewish General Hospital
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Responsible Party: Dr. Vicky Tagalakis, Attending Physician and Clinical Researcher, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT02752607    
Other Study ID Numbers: MM-JGH-16-003
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases