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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: Clinical Trial Phase 3 study, sponsored by University Medical Center Groningen.
NCT01164046 is a Phase 3 study that was terminated before completion, run by University Medical Center Groningen. The registered enrollment target is 56 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Primary efficacy outcome
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 |
Why NCT01164046 stopped before completion
NCT01164046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which low molecular weight heparin is the first listed.
NCT01164046 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01164046's enrollment target sits among peer trials
56 1827th of 2000 higher than 167 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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