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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-018141-20 | EudraCT Number |
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The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Innohep® | Experimental | Long-term treatment with Innohep® only. |
|
| Warfarin | Active Comparator | Oral treatment with warfarin in combination with overlapping initial (5 to 10 days) treatment with Innohep®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Tablets. Once daily for 6 months (180 days) to maintain therapeutic international normalised ratio (INR) levels in combination with initial (5-10 days) overlapping treatment with Innohep®. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite end-point represented by the time in days from randomisation to the first occurrence of VTE |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time in days from randomisation to the first occurrence of VTE. |
Safety endpoints will consist of bleeding and overall mortality | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Y. Y. Lee, MD, MSc, FRCPC | Director of Thrombosis, Division of Hematology, University of British Columbia, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diamond Health Care Centre | Vancouver | British Columbia | BC V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34878173 | Derived | Kahale LA, Matar CF, Hakoum MB, Tsolakian IG, Yosuico VE, Terrenato I, Sperati F, Barba M, Schunemann H, Akl EA. Anticoagulation for the initial treatment of venous thromboembolism in people with cancer. Cochrane Database Syst Rev. 2021 Dec 8;12(12):CD006649. doi: 10.1002/14651858.CD006649.pub8. | |
| 29618162 | Derived |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D000078222 | Tinzaparin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Innohep® | Drug | Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg. |
|
| Bauersachs R, Lee AYY, Kamphuisen PW, Meyer G, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Renal Impairment, Recurrent Venous Thromboembolism and Bleeding in Cancer Patients with Acute Venous Thromboembolism-Analysis of the CATCH Study. Thromb Haemost. 2018 May;118(5):914-921. doi: 10.1055/s-0038-1641150. Epub 2018 Apr 4. |
| 26284719 | Derived | Lee AYY, Kamphuisen PW, Meyer G, Bauersachs R, Janas MS, Jarner MF, Khorana AA; CATCH Investigators. Tinzaparin vs Warfarin for Treatment of Acute Venous Thromboembolism in Patients With Active Cancer: A Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):677-686. doi: 10.1001/jama.2015.9243. |
| 23764005 | Derived | Lee AY, Bauersachs R, Janas MS, Jarner MF, Kamphuisen PW, Meyer G, Khorana AA; CATCH Investigators. CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients. BMC Cancer. 2013 Jun 13;13:284. doi: 10.1186/1471-2407-13-284. |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |