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NCT01164046 · ClinicalTrials.gov registry record · Phase 3
Long-term Treatment for Cancer Patients With Deep Venous Thrombosis or Pulmonary Embolism
A Phase 3 study, sponsored by University Medical Center Groningen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT01164046 is a Phase 3 study that was terminated before completion, run by University Medical Center Groningen. The registered enrollment target is 56 participants.
The verdict
NCT01164046, a Phase 3 study, was terminated before completion, sponsored by University Medical Center Groningen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study Summary
Background Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant treatment. However, it is unknown whether LMWH is still superior compared to VKA for the long-term anticoagulant treatment. Aim The aim of this study is to evaluate whether low-molecular-weight heparin more effectively reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis of the leg or pulmonary embolism. Hypothesis The investigators hypothesize that LMWH is more effective compared to VKA in the long-term treatment of VTE in cancer patients who have already been treated for 6-12 months with anticoagulants. Design This is a multicenter, multinational, randomized, open label trial. Patients Patients with a malignancy (all types, solid and hematological) who have received 6-12 months of anticoagulation for VTE and have an indication for continuing anticoagulation, will be randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be 2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis and pulmonary embolism. The primary safety outcome is major bleeding. Sample size A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To obs
Interventions
- DRUG low molecular weight heparin
- DRUG vitamin K antagonists
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2010-08 |
| Est. Completion | 2014-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01164046
The ClinicalTrials.gov registry entry for NCT01164046 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Medical Center Groningen, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which low molecular weight heparin is the first listed.
NCT01164046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01164046 about?
NCT01164046 is a clinical study titled "Long-term Treatment for Cancer Patients With Deep Venous Thrombosis or Pulmonary Embolism". Background Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of recurrent VTE compa...
What is the current status of trial NCT01164046?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2010-08. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01164046?
The interventions under investigation include: low molecular weight heparin (DRUG), vitamin K antagonists (DRUG).
Who is sponsoring clinical trial NCT01164046?
This trial is sponsored by University Medical Center Groningen, which has 5 total clinical trials registered on ClinicalTrials.gov.
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