Status:
TERMINATED
Reduction to Preventive Doses of Enoxaparin After 3 to 6 Months of Treatment With Blood Thinners for Cancer-associated Blood Clots
Lead Sponsor:
Dr. Vicky Tagalakis
Collaborating Sponsors:
Sanofi
Conditions:
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 9 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02752607
Start Date
May 1 2016
End Date
November 9 2018
Last Update
November 26 2018
Active Locations (7)
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1
Queen Elizabeth II Medical Centre
Halifax, Nova Scotia, Canada, B3H 1V7
2
The Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
3
Hôpital Charles-Le Moyne
Greenfield Park, Quebec, Canada, J4V 2H1
4
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2