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NCT01828697 · ClinicalTrials.gov registry record · Phase 4
Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy
A Phase 4 study of Pulmonary Embolism and Deep Venous Thrombosis, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
- Completed
- Registry status
- Phase 4
- Development phase
- 1,110
- Enrollment target
- 20
- Study locations
NCT01828697 is a Phase 4 study of Pulmonary Embolism and Deep Venous Thrombosis that has completed, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The registered enrollment target is 1,110 participants, below the 3,035-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 2 states.
The verdict
NCT01828697, a Phase 4 study of Pulmonary Embolism and Deep Venous Thrombosis, has completed, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,110 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy. Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.
Conditions Studied
Interventions
- DRUG Low dose nadroparin
- DRUG Intermediate dose nadroparin
- DRUG Low dose enoxaparin
- DRUG Intermediate dose enoxaparin
- DRUG Low dose dalteparin
Study Locations (20)
Other
- KU Leuven - Leuven
- The Ottawa Hospital - Ottawa
- Aalborg University Hospital - Aalborg
- Aarhus University Hospital - Aarhus
- CHU de Besancon - Besançon
- CHU de Bordeaux - Bordeaux
- CHU de Brest - Brest
- CHU de Caen - Caen
- CHU de Clermont - Ferrand - Clermont-Ferrand
- APHP Louis Mourier - Colombes
- CHU de Grenoble - Grenoble
- CHU de Limoges - Limoges
- Hopiteaux de Marseille - Marseille
- Marseille St Joseph - Marseille
- CHU de Nancy - Nancy
- CHU de Nice - Nice
- CHU de Nîmes - Nîmes
- APHP Antoine Béclère - Paris
- APHP Port Royal - Paris
New York
- Weill Cornell Medicine | NewYork-Presbyterian - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,110 participants |
| Start Date | 2013-04-24 |
| Est. Completion | 2021-10-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01828697
The ClinicalTrials.gov registry entry for NCT01828697 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,035-participant average among 48 other Pulmonary Embolism trials with a reported enrollment target (63% lower). The listed sponsor is Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pulmonary Embolism appearing as the primary indexed condition, and to 5 interventions - of which Low dose nadroparin is the first listed.
NCT01828697 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Other, New York.
Frequently Asked Questions
What is clinical trial NCT01828697 about?
NCT01828697 is a clinical study titled "Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy". This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACC...
What is the current status of trial NCT01828697?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,110 participants. The study started on 2013-04-24. Estimated completion is 2021-10-31.
What conditions does trial NCT01828697 study?
This clinical trial studies the following conditions: Pulmonary Embolism, Deep Venous Thrombosis.
What interventions are being tested in trial NCT01828697?
The interventions under investigation include: Low dose nadroparin (DRUG), Intermediate dose nadroparin (DRUG), Low dose enoxaparin (DRUG), Intermediate dose enoxaparin (DRUG), Low dose dalteparin (DRUG).
Who is sponsoring clinical trial NCT01828697?
This trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01828697 being conducted?
This trial has 20 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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